Label: HIELO ARDIENTE- menthol gel
- NDC Code(s): 53145-002-01
- Packager: Menper Distributors, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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
- INDICATIONS & USAGE
- 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 directedClose
- 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.Close
- DOSAGE & ADMINISTRATION
- 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
- store this product between 15°-30°C (59°-86°F)
- INACTIVE INGREDIENT
camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, polysorbate 20, purified water, triethanolamineClose
- INGREDIENTS AND APPEARANCE
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)