Label: ACNE CONTROL- cream cream

  • 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 18, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses

    For the treatment of acne.

  • Warnings

    For external use only.

    When using this product

    • Skin irritation and drynessis 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

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • 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.
    • Rinse off after use.

    Sensitivity Test for a New user. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.

  • Inactive Ingredients

    Water (Aqua), Cocamidopropyl hydroxysultaine, Glycerin, Sodiumj Lauroyl sarcosinate, Sodium Methyl Cocvoyl Taurate, PEG-150 Pentaerythrityl Tetrastearate, Niacinamide, Ceramide NP, Ceramide AP, Ceramide EOP, Carbomer, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Hydrolyzed Hyaluronic Acid, Disodium EDTA, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Xanthan gum, Citric Acid, Sodium Hydroxide.

  • Label Copy

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ACNE CONTROL 
    cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5834
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2000 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    CERAMIDE NP (UNII: 4370DF050B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5834-08236 mL in 1 BOTTLE, PLASTIC; 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 - Walgreen (008965063)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(0363-5834)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!