Label: ANALGESIC BALM- menthol 10%, methyl salicylate 15% cream

  • NDC Code(s): 57896-116-01
  • Packager: Geri-Care Pharmaceuticals, Corp
  • 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 July 29, 2020

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Menthol 10%

  • Active Ingredient

    Methyl Salicylate 15%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

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

  • Warnings

    For external use only

    Do not use:

    • On wounds or damaged, broken or irritated skin
    • On a child under 12 years of age with arthritis-like conditions
    • With a heating pad

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

    When using this product

    • Avoid contact with eyes or mucous membrane
    • Do not bandage tightly
  • Stop Use and ask a doctor

    • Conditions worsens or does not improve within 7 days
    • Symptoms clear up and occur again within a few days
    • Excessive skin irritation develops

  • Keep out of the reach of Children

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

  • Directions

    • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

    Children under 12 years of age. consult a doctor

    • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
  • Other Information

    • Store at controlled room temperature 20º-25ºC (68º-77ºF)

    Questions ? Call 1-800-540-3765

  • Inactive Ingredients

    Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

  • Distributed By

    GeriCare Pharmaceuticals

    1650 63rd Street

    Brooklyn, NY 11204

    Product of China

  • Packaging

    gc analgesic balm 1oz

  • INGREDIENTS AND APPEARANCE
    ANALGESIC BALM 
    menthol 10%, methyl salicylate 15% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-116-011 in 1 BOX08/05/2020
    128 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 finalpart34808/05/2020
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
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!