Label: PHARMACYS PRESCRIPTION ANALGESIC GEL- menthol gel

  • NDC Code(s): 72197-001-08
  • Packager: American Consumer Products Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 9, 2023

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

View All Sections
  • Active Ingredient

    Active Ingredient: Menthol 1%

  • Purpose

    Purpose: Pain relieving gel

  • Warnings

    Warnings: For external use only

  • Stop Use

    Stop use and ask 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

    Keep our of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Inactive Ingredients

    Inactive Ingredients

    carbomer, isopropyl alcohol, nonyl phenyl polyoxyethylene ether, camphor, kathon CG, FD&C blue no. 1, triethanolamine, water

  • Indications & Usage Section

    Uses: For the temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - bruses - sprains

    When using this product

    - avoid contact with eyes

    - do not bandage tightly

    - do not apply to wounds or damaged skin

    - do not use with heating pads or other heating devices

  • Dosage & Administration

    Directions

    - adults and childrent 2 years of age and older: apply to affected area not more than 3 to 4 times daily

    - children under 2 years of age: do not use, consult a doctor

  • Pharmacy's Prescription 8 OZ Ice Cold Analgesic Gel

    Pharmacys Prescription 8 OZ Ice Cold Analgesic

  • INGREDIENTS AND APPEARANCE
    PHARMACYS PRESCRIPTION ANALGESIC GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72197-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    2,2',3,3',4,4',5,5',6-NONACHLORODIPHENYL ETHER (UNII: 4S0765P9W8)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72197-001-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/31/2018
    Labeler - American Consumer Products Corp (081101181)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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