Label: FIRST AID BEAUTY FAB PHARMA WHITE CLAY ACNE TREATMENT- salicylic acid disc

  • 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.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment of acne
  • Warnings

    For external use only.

    Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

    If irritation occurs, only use one topical acne medication at a time.

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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:

    888-FAB-3063

  • SPL UNCLASSIFIED SECTION

    MADE IN USA

    FIRST AID BEAUTY LTD

    NEWTON, MA 02458

    WWW.FIRSTAIDBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL - 60 pads carton

    First Aid Beauty

    FAB

    Pharma

    White Clay Acne Treatment Pads

    2% Salicylic Acid

    Safe for sensitive skin

    FIrst Aid Beauty ®

    60 PADS 2.25 IN (5.7 CM) DIAM

    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY FAB PHARMA WHITE CLAY ACNE TREATMENT 
    salicylic acid disc
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-555-601 in 1 CARTON01/01/2021
    160 in 1 JAR
    11 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novacyl263624659api manufacture(69423-555)