Label: WALGREENS PAIN RELIEVING ANALGESIC (camphor- synthetic, menthol, unspecified form, and methyl salicylate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 25, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients  Purpose
    Camphor 4%Topical Analgesic
    Menthol 10.0%Topical Analgesic
    Methyl Salicylate 30%Topical Analgesic
  • Uses

    for the temporary relief of minor aches and muscles and joints associated with

    ♦
    arthritis
    ♦
    simple backache
    ♦
    strains
    ♦
    sprains
  • Warnings

    For external use only. ALLERGY ALERT if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Avoid contact with eyes and mucous membranes.

    Do not use

    ♦
    for arthritis-like conditions in children under 12. Consult a doctor.
    ♦
    with a heating pad
    ♦
    on wounds or damaged skin

    If pregnant or breast feeding ask a health professional before use

    When using this product

    ♦
    use only as directed
    ♦
    do not swallow
    ♦
    do not bandage tightly

    Stop use and consult a doctor if

    ♦
    condition worsens or pain lasts for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    ♦
    Adults and children 12 years of age and older: apply to affected area not more than 3 or 4 times daily. Children under 12 years of age: consult a doctor
  • Other information

    Store at room temperature

  • Inactive ingredients

    Carbomer, Disodium EDTA, Glyceryl Stearate SE, Lanolin, Polysorbate 80, Potassium Hydroxide, Stearic Acid, Triethanolamine, Water.

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    Walgreens

    Compare to Ultra Strength
    BENGAY® active ingredients††

    Pain
    Relieving
    Cream

    CAMPHOR 4% / MENTHOL 10% /
    METHYL SALICYLATE 30% /
    TOPICAL ANALGESIC

    ULTRA STRENGTH

    NON-GREASY

    • Relief from minor arthritis,
      backache, muscle & joint pain

    NET WT 4 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WALGREENS PAIN RELIEVING   ANALGESIC
    camphor (synthetic), menthol, unspecified form, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1199
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Lanolin (UNII: 7EV65EAW6H)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1199-011 in 1 CARTON02/11/2020
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34802/11/2020
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(0363-1199)
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