Label: GELIGA MUSCULAR- menthol, methyl salicylate cream

  • NDC Code(s): 60954-004-30, 60954-004-60
  • Packager: Eagle Indo Pharma, PT
  • 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 September 7, 2023

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  • Active Ingredients

    • Menthol 3%
    • Methyl Salicylate 10%
  • Purpose

    External Analgeisc

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises, and sprains.

  • Warnings

    For external use only.

    Avoid contact with the eyes or mucous membrane.

    When using this product

    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
    • Do not use otherwise than as directed.

    Stop use and ask doctor if

    • Condition worsens.
    • Symptoms persist for more than 7 days or clear up and occur again within a few days.
    • Pain persists for more than 10 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 to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

  • Directions

    • Apply liberally and rub gently onto affected area.
    • Adults and children of 12 years of age and older, apply not more than 3 to 4 times daily.
    • Children under 12 years of age, consult a doctor before using.
  • Other information

    Store below 86 oF (30 oC).

  • Inactive Ingredients

    Butylparaben, Carbomer, Ethylparaben, Fragrance, Glycerin, Methylparaben, Methyl glucose dioelate, Phenoxyethanol, Propylparaben, Trolamine, Water

  • Questions

    Contact us at 1-800-645-0769

  • Package Label

    30g NDC: 60954-004-30

    30g Unit Box

  • Package Label

    60g NDC: 60954-004-60

    60g Unit Box

  • INGREDIENTS AND APPEARANCE
    GELIGA  MUSCULAR
    menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60954-004-301 in 1 BOX05/08/2023
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:60954-004-601 in 1 BOX05/08/2023
    260 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 finalpart34805/08/2023
    Labeler - Eagle Indo Pharma, PT (728682519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Indo Pharma, PT728682519manufacture(60954-004)
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