HIELO ARDIENTE- menthol gel

Hielo Ardiente by

Drug Labeling and Warnings

Hielo Ardiente by is a Otc medication manufactured, distributed, or labeled by Menper Distributors, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Menthol 1%

PURPOSE

Purpose

Analgesic

INDICATIONS & USAGE

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

WARNINGS

Use only as directed

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HIELO ARDIENTE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-002
Route of Administration	TOPICAL

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)