Label: MEIJER ULTRA STRENGTH PAIN RELIEVING TOPICAL ANALGESIC (camphor- synthetic, menthol, unspecified form, and methyl salicylate cream

  • NDC Code(s): 79481-1220-1
  • Packager: Meijer Distribution, INC
  • Category: HUMAN OTC DRUG LABEL

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 January 7, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Camphor 4%Topical analgesic
    Menthol 10%Topical analgesic
    Methyl salicylate 30%Topical analgesic
  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with

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

    For external use only.

    ALLERGY ALERT if prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Avoid contact with the 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 breastfeeding ask a health professional before use.

    When using this product

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

    Stop use and ask a doctor

    • if condition worsens, or if symptoms persist 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 to 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?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    meijer®

    Compare to Ultra Strength
    BENGAY® Active
    Ingredients*

    NDC 79481-1220-1

    ULTRA
    STRENGTH

    pain
    relieving
    cream

    Camphor 4% | Menthol 10% |
    Methyl Salicylate 30%

    For Arthritis, Simple
    Backache, Strains,
    Sprains, and Bruises

    Non-Greasy

    NET WT 4 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MEIJER ULTRA STRENGTH PAIN RELIEVING   TOPICAL ANALGESIC
    camphor (synthetic), menthol, unspecified form, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-1220
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (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:79481-1220-11 in 1 CARTON11/30/2020
    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 FINALpart34811/30/2020
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(79481-1220)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!