Label: BUFFERIN PAIN RELIEF- menthol, camphor, 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 August 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Camphor 4%, Menthol 10% Methyl salicylate 30%

  • Purpose

    Topical analgesics

  • Uses

    Temporarily relieves the minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Allergy alert

    • If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have redness over the affected area.

    When using this product

    • use only as directed
    • avoid contact with eyes or mucous membranes or rashes
    • do not bandage tightly

    Stop use and ask a doctor If

    • redness is present or irritation or rash develops
    • conditions worsen or symptoms clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • use only as directed

    Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daiIy

    Chidren under 12 years of age: ask a doctor

  • Other information

    • store at 15 to 30"C (59 to 86"F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    Purified water, Glycerin, Glycerol monostearate (GMS), Stearyl alcohol, Cetyl alcohol, Hemp seed oil, Stearic acid, Isopropyl palmitate, Polyacrylic acid, Potassium cetyl phosphate, Triethanolamine (TEA), Methylparaben, Propylparaben

  • Questions or comments?

    Call toll free 1-877-994-3666

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    GENOMMA LAB USA, INC.,
    HOUSTON, TX 77098

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

    irwin
    naturals®

    BUFFERIN®
    + 1000 mg
    Hemp Seed Oil*
    PER TUBE
    CURATED FROM IRWIN NATURALS®

    PAIN RELIEF CREAM
    ULTRA STRENGTH

    FAST ACTING
    DEEP PENETRATING
    *FOR SKIN CONDITIONING

    FAST RELIEF OF MUSCLE,
    BACK AND JOINT PAIN

    NET. WT 2.0 OZ (56.7 g)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BUFFERIN PAIN RELIEF 
    menthol, camphor, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-615
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-100 mg  in 1 g
    CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-40 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    Stearyl alcohol (UNII: 2KR89I4H1Y)  
    cetyl alcohol (UNII: 936JST6JCN)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-615-201 in 1 CARTON08/18/2023
    156.7 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 finalpart34808/18/2023
    Labeler - Genomma Lab USA (832323534)
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