Label: SALICYLIC ACID ACNE TREATMENT- salicylic acid soap

  • NDC Code(s): 74553-012-01
  • Packager: Xtreme Tools International, Inc
  • 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 September 7, 2023

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  • Drug Facts

  • Active Ingredient

    Salicylic Acid (2%)

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne.

  • Warning

    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 medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Wet face. Work soap into a lather with hands and gently massage onto skin. Rinse.

  • Inactive Ingredients

    Sodium Palmate, Sodium Palm Kernelate, Sodium Cocoate, Water (Aqua), Glycerin, Cocos nucifera (Coconut)
    Oil, Leptospermum Scoparium Branch/Leaf (Manuka) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Calendula Officinalis
    Flower Extract, Aloe Barbadensis Leaf Extract, Allantoin, Tocopheryl Acetate, Tetrasodium Etidronate, Sodium Chloride, Fragrance.

  • QUESTIONS

    Questions or comments?
    Call 1-305-622-7474 Mon-Fri 9 am-5 pm

  • PACKAGE LABEL

    NDC 74553-012-01 

    body-soap-bar

  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID ACNE TREATMENT 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MANUKA OIL (UNII: M6QU9ZUH2X)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74553-012-01255 g in 1 BOX; Type 0: Not a Combination Product09/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00609/11/2023
    Labeler - Xtreme Tools International, Inc (125398904)
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