Label: RITE AID RENEWAL- salicylic acid 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 July 29, 2011

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  • ACTIVE INGREDIENT

    SALICYLIC ACID 2.0%

  • PURPOSE

    ACNE TREATMENT

  • USES

    For the treatment of Acne

  • WARNINGS

    FOR EXTERNAL USE ONLY

    ASK DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

    USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR  CONTACT POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    CLEANSE TWO TIMES A DAY. WET FACE. APPLY TO HANDS ADD WATER AND WORK INTO LATHER. MASSAGE FACE GENTLY. RINSE WELL.

  • QUESTIONS OR COMMENTS

    1-866-695-3030

  • INACTIVE INGREDIENTS

    WATER, CETYL ALCOHOL, PPG-15 STEARYL ETHER, POLYETHYLENE, GLYCOLIC ACID, GLYCERIN, POLYSORBATE 60, STEREATH-21, C12-15 ALKYL LACTATE, CETYL LACTATE, BHT, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, POTASSIUM CETYL PHOSPHATE, DISODIUM EDTA, XANTHAN GUM, SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE, SODIUM HYDROXIDE, AGAR, MENTHOL, BENZALKONIUM CHLORIDE, MICA, TITANIUM DIOXIDE, RED 40 (CI 16035), RED 33  (CI 17200), YELLOW 5 (CI 19140),  FRAGRANCE  (PARFUM)

  • LABEL COPY

    image of the label

  • INGREDIENTS AND APPEARANCE
    RITE AID RENEWAL 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-8210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-15 (UNII: O6V041E38J)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    AGAR (UNII: 89T13OHQ2B)  
    MENTHOL (UNII: L7T10EIP3A)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-8210-5125 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/03/2011
    Labeler - RITE AID CORPORATION (014578892)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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