Label: 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 28, 2011

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  • ACTIVE INGREDIENT

    SALICYLIC ACID 2.0%
  • PURPOSE

    ACNE TREATMENT

  • USES

    USES

  • 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 A 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/COMMENTS?

    1-866-695-3030

  • INACTIVE INGREDIENTS

    WATER, SODIUM C14-16 OLEFIN SULFONATE, GLYCERIN, COCAMIDOPROPYL BETAINE, STEARYL ALCOHOL, CETYL ALCOHOL, GLYCERYL STEARATE, SODIUM METHYL COCOYL TAURATE, POTASSIUM CETYL PHOSPHATE, HYDROXYPROPYL METHYLCELLULOSE, CETYL LACTATE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, PROPYLENE GLYCOL, SODIUM CHLORIDE, BENZALKONIUM CHLORIDE, FRAGRANCE.

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    RENEWAL  
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-8200
    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)  
    SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-8200-7200 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/28/2011
    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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