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 Type HUMAN OTC DRUG Item Code (Source) NDC:53145-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4840 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53145-002-01 1 in 1 CARTON
1 484 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/21/2012
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.