Refissa

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Refissa Recall

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Side Effects & Adverse Reactions

Do not use if glued carton en flaps are open or if the single-use dose container is not intact.
Do not use if solutions changes color or becomes cloudy.

Stop use and ask doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

To avoid contamination:
Do not touch tip of container to any surface.
Do not the eye with the tip of the container.
Do not reuse
Once opened, discard container after each use.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Temporarily relieves minor eye irritation due to fatigue or airborne irritants such as ragweed, other pollens and dust.

Soothes red, dry, itchy, burning or tired eyes.

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Refissa Manufacturers

Obagi Medical Products, Inc.

Refissa | Laboratoires Boiron

Snap off one single-use dose. Twist to open. Instill 1 to 2 drops, or more if necessary in affected eye(s). Repeat 2 to 6 times a day, as needed, or as directed by a doctor.

No Recall
Coria Laboratories, Ltd

Refissa | Procter & Gamble Manufacturing Company

apply to underarms only

No Recall
Suneva Medical, Inc.

Refissa | Suneva Medical, Inc.

Do NOT use Tretinoin Cream, USP (Emollient) if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy Do NOT use Tretinoin Cream, USP (Emollient) if the patient is sunburned or if the patient has eczema or other chronic skin conditions of the face Do NOT use Tretinoin Cream, USP (Emollient) if the patient is inherently sensitive to sunlight Do NOT use Tretinoin Cream, USP (Emollient) if the patient is also taking drug(s) known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

Tretinoin Cream, USP (Emollient) should be applied to the face once a day in the evening, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Tretinoin Cream, USP (Emollient). The patient should apply a pea-sized amount of cream to cover the entire affected face lightly. Caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of Tretinoin Cream, USP (Emollient) may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Tretinoin Cream, USP (Emollient) 0.05% is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Tretinoin Cream, USP (Emollient) 0.05% therapy, a majority of patients will lose most mitigating effects of Tretinoin Cream, USP (Emollient) 0.05% on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks have not been established.

Application of larger amounts of medication than recommended may not lead to more rapid results or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with Tretinoin Cream, USP (Emollient) 0.05% may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied. (See PRECAUTIONS section.)

No Recall
Spear Dermatology Products

Refissa | Spear Dermatology Products

Do NOT use Refissa [Tretinoin Cream, USP (Emollient) 0.05%] if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy Do NOT use Refissa if the patient is sunburned or if the patient has eczema or other chronic skin condition(s) Do NOT use Refissa if the patient is inherently sensitive to sunlight Do NOT use Refissa if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

Refissa should be applied to the face once a day before retiring, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Refissa. The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of Refissa [Tretinoin Cream, USP (Emollient) 0.05%] may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Refissa is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Refissa therapy, a majority of patients will lose most mitigating effects of Refissa on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Refissa daily for greater than 48 weeks have not been established.

Application of larger amounts of medication than recommended may not lead to more rapid results or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with Refissa may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied. (See PRECAUTIONS section.)

No Recall
Suneva Medical, Inc.

Refissa | Suneva Medical, Inc.

Do NOT use Refissa [Tretinoin Cream, USP (Emollient) 0.05%] if the patient is pregnant or is attempting to become pregnant or is at high risk of pregnancy Do NOT use Refissa if the patient is sunburned or if the patient has eczema or other chronic skin condition(s) Do NOT use Refissa if the patient is inherently sensitive to sunlight Do NOT use Refissa if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity.
Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The physician should review the Patient Package Insert.

Refissa should be applied to the face once a day before retiring, using only enough to cover the entire affected area lightly. Patients should gently wash their faces with a mild soap, pat the skin dry, and wait 20 to 30 minutes before applying Refissa. The patient should apply a pea-sized amount of cream to cover the entire face lightly. Special caution should be taken when applying the cream to avoid the eyes, ears, nostrils, and mouth.

Application of Refissa [Tretinoin Cream, USP (Emollient) 0.05%] may cause a transitory feeling of warmth or slight stinging.

Mitigation (palliation) of facial fine wrinkling, mottled hyperpigmentation, and tactile roughness may occur gradually over the course of therapy. Up to six months of therapy may be required before the effects are seen. Most of the improvement noted with Refissa is seen during the first 24 weeks of therapy. Thereafter, therapy primarily maintains the improvement realized during the first 24 weeks.

With discontinuation of Refissa therapy, a majority of patients will lose most mitigating effects of Refissa on fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin; however, the safety and effectiveness of using Refissa daily for greater than 48 weeks have not been established.

Application of larger amounts of medication than recommended may not lead to more rapid results or better results, and marked redness, peeling, or discomfort may occur.

Patients treated with Refissa may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied. (See PRECAUTIONS section.)

No Recall