Label: MOTHER DIRT DAILY WITH SALICYLIC ACID- acne lotion

  • 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 January 13, 2023

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  • Active Ingredient

    Salicylic Acid 0.5%

    Purpose

    Acne Treatment

  • Use

    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 thoroughly with water.

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

  • Directions

    Clean the skin thoroughly before applying this product.

    Cover the entire affected area with a thin layer one to three times daily.

    Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.

  • Other Information

    Store in a cool, dry place

  • Inactive Ingredients

    water, glycerin, ethyl linoleate, astrocaryum tucuma seed butter, glyceryl cocoate, jojoba esters, ethyl olivate, lactobacillus ferment, galactoarabinan, cellulose, glucomannan, glycolipids, lactobacillus, morinda citrifolia extract, chitosan, arginine, cocos nucifera (coconut) fruit extract, stellaria media (chickweed) extract, olea europaea (olive) leaf extract, bacillus ferment

  • 0.91 fl oz package

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  • INGREDIENTS AND APPEARANCE
    MOTHER DIRT DAILY  WITH SALICYLIC ACID
    acne lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80646-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.501 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5)  
    ETHYL OLIVATE (UNII: KKJ108Y20W)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    GLYCERYL COCOATE (UNII: WVK1CT5994)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT (UNII: 3RT3536DHY)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    ETHYL LINOLEATE (UNII: MJ2YTT4J8M)  
    ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)  
    LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ARGININE (UNII: 94ZLA3W45F)  
    WATER (UNII: 059QF0KO0R)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STELLARIA MEDIA (UNII: 2H03479QVR)  
    CHITOSAN MEDIUM MOLECULAR WEIGHT (200-800 MPA.S) (UNII: 82LKS4QV2Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80646-100-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/05/202008/01/2023
    Labeler - MBX Llc (116939094)
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