Label: FIRST AID BEAUTY FAB ACNE SPOT TREATMENT- salicylic acid gel

  • NDC Code(s): 69423-724-22
  • 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 July 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment of acne
  • Warnings

    For external use only.

    When using this product

    • 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.

    Stop use and ask a doctor if skin irritation occurs/gets worse.

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

  • Directions

    • clean facial skin thoroughly before applying
    • apply to face with a thin layer one to three tim es daily
    • start with one application daily to avoid excessive drying of the skin
    • gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce application
  • INACTIVE INGREDIENT

    Water, butylene glycol, hydroxyethylcellulose,glycerin, phenoxyethanol, sodium hydroxide, glycolic acid, urea, aloe barbadensis leaf juice, bisabolol, colloidal oatmeal, maltodextrin, carica papaya (papaya) fruit extract, potassium sorbate, sodium benzoate, camellia sinensis leaf extract, chrysanthemum parthenium (feverfew) extract, glycyrrhiza glabra (licorice) root extract, salix nigra (willow) bark extract, disodium phosphate, polysorbate 60, leuconostoc/radish root ferment filtrate, sodium phosphate, citric acid

  • Questions:

    888-FAB-3063

  • SPL UNCLASSIFIED SECTION

    MADE IN USA

    FIRST AID BEAUTY LTD

    NEWTON, MA 02458

    WWW.FIRSTAIDBEAUTY.COM

  • PRINCIPAL DISPLAY PANEL - 22 mL carton

    FIrst Aid Beauty ®

    FAB

    ACNE SPOT

    TREATMENT GEL

    2% Salicylic Acid

    Safe for sensitive skin

    22 mL (0.75 FL OZ)

    FAB

  • INGREDIENTS AND APPEARANCE
    FIRST AID BEAUTY FAB ACNE SPOT TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-724
    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
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OATMEAL (UNII: 8PI54V663Y)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    UREA (UNII: 8W8T17847W)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PAPAYA (UNII: KU94FIY6JB)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-724-221 in 1 CARTON08/01/2023
    122 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00608/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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