HIELO ARDIENTE- menthol gel 
Menper Distributors, Inc.

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.

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Active ingredient

Menthol 1%

Purpose

Analgesic

Warnings

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

Other information

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
Document Id: 4000c212-7fc1-47b8-a4c0-29fce9835e3d
Set id: 97ec516c-d2bc-47ce-82fe-bd68445d9570
Version: 1
Effective Time: 20130916
 
Menper Distributors, Inc.