Label: 3-1 ACNE TREATMENT PADS- salicylic acid swab

  • 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 November 2, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2.0% w/w Acne Treatment

  • Purpose

    Acne Treatment

  • Uses

    Treats and helps prevent acne.

  • Warnings For external use only.

    Flammable - keep away from extreme heat or open flame.

    When using this product Avoid contact with eyes, lips and mouth. If contact with eyes occurs, rinse eves thoroughly with water.

    Do not use this product if you have a known allergy to salicylic acid or aspirin.

    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.

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

  • 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.
  • Inactive Ingredients

    Allantoin, Capryloyl Glycine, Disodium EDTA, Ethanol, Fragrance, Isoceteth-20, Jojoba Wax PEG-120 Esters, Phytic Acid, Water

  • Principal Display Panel – 90 Pads Jar Label

    CVSHealth™

    Compare to the active ingredient
    in OXY® Acne Medication
    Rapid Treatment 3-in-1 Pads*

    NDC # 66902-990-90

    3-in-1
    Acne Treatment
    Pads

    2% SALICYLIC ACID

    Helps clear up acne pimples
    and blackheads

    • Penetrates pores to clear
      most acne blemishes
    • Helps clear skin
    • Helps prevent future breakouts

    90 PADS 2.25 IN (5.7 cm)

    Principal Display Panel – 90 Pads Jar Label
  • INGREDIENTS AND APPEARANCE
    3-1 ACNE TREATMENT PADS 
    salicylic acid swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-990
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid0.024 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOCETETH-20 (UNII: O020065R7Z)  
    ETHYL JOJOBATE (UNII: 2351QH8W1N)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-990-9090 in 1 JAR; Type 0: Not a Combination Product11/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/02/2020
    Labeler - Natural Essentials, Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-990)
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