Label: THE BETTER SKIN CO. ZIT NO MORE KLEANSE- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71716-101-02 - Packager: Mirakle Cosmetics LLC dbaThe Better Skin Co.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 June 26, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- use twice a day, morning and night
- lather between palms with water, Massage in circular motion on wet skin. Rinse well
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follow directions above
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 163 mL Bottle Label
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INGREDIENTS AND APPEARANCE
THE BETTER SKIN CO. ZIT NO MORE KLEANSE
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71716-101 Route of Administration CUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) GLYCERIN (UNII: PDC6A3C0OX) TEA TREE OIL (UNII: VIF565UC2G) SODIUM HYDROXIDE (UNII: 55X04QC32I) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71716-101-02 163 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 09/01/2018 Labeler - Mirakle Cosmetics LLC dbaThe Better Skin Co. (076387672) Establishment Name Address ID/FEI Business Operations Innovative Cosmetic Labs 961693657 MANUFACTURE(71716-101)
