Label: CLEAR BLEMISH TREATMENT JAFRA- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-129-01, 68828-129-02 - 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 ingredient Purpose
Salicylic Acid 2% Acne treatment Gel
Uses
treats acne
dries up acne pimples
helps prevent new acne pimples
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
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 bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive Ingredients: Acrylates/C10-30 Alkyl acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Denatonium Benzoate, Disodium Phosphate, Ethoxydiglycol, Eugenia Caryophyllus (clove) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Melia Azadirachta Extract, Panthenol, PPG-5 Ceteth-20, Propylene Glycol, Saccharide Isomerate, Salvia Sclarea (Clary) Oil, SD Alcohol 40-B/Alcohol Denat, Colloidal Sulfur, Water/Aqua, Xanthan Gum, Yeast Extract.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAR BLEMISH TREATMENT JAFRA
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 151 mL Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CLOVE LEAF OIL (UNII: VCA5491KVF) LAVENDER OIL (UNII: ZBP1YXW0H8) AZADIRACHTA INDICA BARK (UNII: G580B439YI) PANTHENOL (UNII: WV9CM0O67Z) PPG-5-CETETH-20 (UNII: 4AAN25P8P4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIDE ISOMERATE (UNII: W8K377W98I) CLARY SAGE OIL (UNII: 87L0D4U3M0) XANTHAN GUM (UNII: TTV12P4NEE) YEAST (UNII: 3NY3SM6B8U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-129-02 1 in 1 BOX 06/19/2012 1 NDC:68828-129-01 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 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(68828-129)
