Label: SKINCOACH TREAT- benzoyl peroxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73047-002-01 - Packager: SKIN COACH SL.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 21, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
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Warnings
When using this product avoid unnecessary sun exposure and use a sunscreen. ■ For external use only ■ Keep away from eyes, lips, and mouth ■ If irritation develops discontinue use and consult a doctor ■ Using other topical acne medications at the same time or immediately,
following use of this product may increase dryness or irritation of the skin. If this occurs consult a doctor. ■May bleach fabrics. - KEEP OUT OF REACH OF CHILDREN
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Directions
■ Cleanse the skin thoroughly belore applying. ■ Apply a thin layer daily,then gradually increase to two or three times daily. ■ If bothersome drying or peeling occurs, reduce applications. ■ If going outside, use a sunscreen. If initation or sensitivity develops, discontinue use of both products and consult a doctor.
- Inactive ingredients
- DOSAGE & ADMINISTRATION
- Principal display panel
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INGREDIENTS AND APPEARANCE
SKINCOACH TREAT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73047-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73047-002-01 57 g in 1 TUBE; Type 0: Not a Combination Product 05/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 05/21/2019 Labeler - SKIN COACH SL. (468534978) Registrant - SKIN COACH SL. (468534978) Establishment Name Address ID/FEI Business Operations Topiderm Inc. II 078841698 manufacture(73047-002)
