Label: MATTIFYING TONIC JAFRA- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-102-01 - Packager: JAFRA COSMETICS INTERNATIONAL
- 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 22, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Salicylic Acid 0.5% Acne Treatment
When using this product
Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Warnings
For external use only.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Clean the skin thoroughly before applying.
Cover the entire affected area with a thin layer 1 to 3 times daily.
Avoid contact with eyes
Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MATTIFYING TONIC JAFRA
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength SULISOBENZONE (UNII: 1W6L629B4K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) KAOLIN (UNII: 24H4NWX5CO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) WATER (UNII: 059QF0KO0R) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-102-01 1 in 1 CARTON 06/19/2012 1 200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/19/2012 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-102)