Label: FIRST AID BEAUTY FAB PHARMA WHITE CLAY ACNE TREATMENT- salicylic acid disc
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Contains inactivated NDC Code(s)
NDC Code(s): 69423-555-60 - Packager: The Procter & Gamble Manufacturing Company
- 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 February 1, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
• Cleanse the skin thoroughly before applying the product.
• Wipe pad across all zones of face once or twice daily after cleansing. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 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. -
INACTIVE INGREDIENT
Water/aqua/eau, polysorbate 80, phenoxyethanol, sodium hydroxide, glycerin, sodium citrate, kaolin, salix nigra (willow) bark extract, rosmarinus officinalis (rosemary) leaf essential oil, butylene glycol, potassium sorbate, sodium benzoate, camellia sinensis leaf extract, chrysanthemum parthenium (feverfew) extract, glycyrrhiza glabra (licorice) root extract, capryloyl glycine, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, sarcosine, leuconostoc/radish root ferment filtrate, enantia chlorantha bark extract, epilobium angustifolium flower/leaf/stem extract, cinnamomum zeylanicum bark extract, xanthan gum, D-limonene, oleanolic acid
- Questions:
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 60 pads carton
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INGREDIENTS AND APPEARANCE
FIRST AID BEAUTY FAB PHARMA WHITE CLAY ACNE TREATMENT
salicylic acid discProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-555 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 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) ROSEMARY OIL (UNII: 8LGU7VM393) EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D) CINNAMON BARK OIL (UNII: XE54U569EC) XANTHAN GUM (UNII: TTV12P4NEE) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) LIMONENE, (+)- (UNII: GFD7C86Q1W) TEA TREE OIL (UNII: VIF565UC2G) KAOLIN (UNII: 24H4NWX5CO) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CITRATE (UNII: 1Q73Q2JULR) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SARCOSINE (UNII: Z711V88R5F) SALIX NIGRA BARK (UNII: QU52J3A5B3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-555-60 1 in 1 CARTON 01/01/2021 1 60 in 1 JAR 1 1 mL in 1 PATCH; 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 01/01/2021 Labeler - The Procter & Gamble Manufacturing Company (004238200) Establishment Name Address ID/FEI Business Operations Novacyl 263624659 api manufacture(69423-555)