Label: WELL AT WALGREENS PINK GRAPEFRUIT- salicylic acid liquid

  • 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 March 17, 2016

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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 otherwise 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 a 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

    • Use daily in the shower or bath. Gently massage on wet skin with washcloth or body puff, concentrating on areas prone to breakouts. Rinse thoroughly.
  • Other information

    • Store between 20°C-25°C (68-77°F)
  • Inactive ingredients

    Water (Aqua), Sodium C14-16 Olefin Sulfonate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Acrylates Crosspolymer-4, Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyquaternium-7, Citrus Grandis (Grapefruit) Fruit Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Chondrus Crispus (Carrageenan) Powder, Neopentyl Glycol Dicaprylate/Dicaprate, Ascorbyl Palmitate, Propylene Glycol, C12-15 Alkyl Lactate, Polysorbate 20, Butylene Glycol, Polyvinyl Alcohol, Disodium EDTA, Sodium Hydroxide, Benzalkonium Chloride, Sodium Benzotriazolyl Butylphenol Sulfonate, Agar, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Mica, Red 30 (CI 73360), Red 40 (CI 16035), Ext. Violet 2 (CI 60730), Fragrance (Parfum).

  • Questions/comments?

    1-800-925-4733

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    WELL AT WALGREENS  PINK GRAPEFRUIT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0829
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    PUMMELO (UNII: ET1TN5W71X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
    AGAR (UNII: 89T13OHQ2B)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0829-08251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/16/2016
    Labeler - WALGREEN COMPANY (008965063)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(0363-0829)
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