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Hielo Ardiente

Medically reviewed by Drugs.com. Last updated on Sep 7, 2020.

Dosage form: gel
Ingredients: MENTHOL 4840mg in 1g
Labeler: Menper Distributors, Inc.
NDC Code: 53145-002

Active ingredient

Menthol 1%

Purpose

Analgesic

Warnings

  • For external use only
  • Do not use if condition worsens
  • If symptoms persist for more than 5 days or recur, discontinue use and consult a physician
  • Do not apply to open wounds or damaged skin
  • Do not bandage tightly
  • Do not use with heating pads or heating devices
  • Avoid contact with eyes

Use only as directed

Keep out of reach of children.

In case of accidental ingestion, contact a doctor or a Poison Control Center right away.

Directions

  • Adults and children 12 years of age or older: Apply to affected area no more than 3 to 4 times daily. Children under 12 years of age, consult a physician
  • Cleanse and dry skin. May be used with wet or dry bandages in conjuction with ice packs.

Other information

  • store this product between 15°-30°C (59°-86°F)

Inactive ingredients

camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, polysorbate 20, purified water, triethanolamine

HIELO ARDIENTE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4840 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
CARBOMER 940 
FD&C BLUE NO. 1 
ISOPROPYL ALCOHOL 
METHYLCHLOROISOTHIAZOLINONE 
POLYSORBATE 20 
WATER 
TRIETHANOLAMINE BENZOATE 
Packaging
#Item CodePackage Description
1NDC:53145-002-011 JAR in 1 CARTON
1484 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/21/2012
Labeler - Menper Distributors, Inc. (101947166)

 
Menper Distributors, Inc.

Further information

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