Label: MEIJER ULTRA STRENGTH PAIN RELIEVING CREAM- camphor, menthol, 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 31, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients Purposes

    Camphor 4%...................................Topical analgesic

    Menthol 10%...................................Topical analgesic

    Methyl salicylate 30%......................Topical analgesic

  • PURPOSE

    Uses

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

    • sprains
    • simple backache
    • arthritis
    • strains
    • bruises
  • WARNINGS

    Warnings

    For external use only

    Allergy alert

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

  • DO NOT 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 DOCTOR

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

  • WHEN USING

    When using this product

    • do not use otherwise than as directed
    • avoid contact with eyes, mucous membranes or rashes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • redness is present or irritation or rash develops
    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    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 daily
    • children under 12 years of age: ask a doctor
  • DOSAGE & ADMINISTRATION

    Other Information

    • store at room temperature 20-25ºC (68-77ºF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

  • PRINCIPAL DISPLAY PANEL

    25350

  • INGREDIENTS AND APPEARANCE
    MEIJER ULTRA STRENGTH PAIN RELIEVING CREAM 
    camphor, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-8227
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLPARABEN (UNII: 14255EXE39)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-8227-21 in 1 CARTON07/08/2020
    157 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 finalpart34807/08/2020
    Labeler - MEIJER, INC. (006959555)