Your browser does not support JavaScript! HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.]
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HIELO ARDIENTE (menthol) gel
[Menper Distributors, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

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 Label

HIELO ARDIENTE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:53145-002-011 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)

Revised: 9/2013
 
Menper Distributors, Inc.

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