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Ice Cold Analgesic by Volume Distributors, Inc.

Dosage form: gel
Ingredients: MENTHOL 1g in 100g
Labeler: Volume Distributors, Inc.
NDC Code: 50523-087

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.

Active Ingredient                   Purpose

Menthol 1.0% ............. Topical Analgesic

Uses temporarily relieves:

  • minor muscle aches and pains

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DT for your DailyTouch

Ice Cold Analgesic Gel

Gel Frio Antimuscular

Directions

For the temporary relief of minor muscle aches and pains.

See important warnings under "When using this product"

  • not for use on children under 2 years of age
  • adults & children 2 years & older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.

Warnings

For external use only; avoid contact with eyes.

Ask a doctor before use if you have cough associated with 

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product,do not:

  • heat
  • microwave
  • add to hot water or any container where healing water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take my mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult a doctor and discontinue use: if condition worsens, persists for more than 1 week or tends to recur.

Inactive Ingredients

camphor, carbomer, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

ICE COLD ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50523-087
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) 
CARBOMER COPOLYMER TYPE A 
FD&C BLUE NO. 1 
ISOPROPYL ALCOHOL 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:50523-087-01227 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2015
Labeler - Volume Distributors, Inc. (002029544)
Establishment
NameAddressID/FEIOperations
Volume Distributors, Inc.002029544manufacture(50523-087)

 
Volume Distributors, Inc.

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Medically reviewed on Jul 10, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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