HIELO MINERAL- external analgesic liquid

Hielo Mineral by

Drug Labeling and Warnings

Hielo Mineral by is a Otc medication manufactured, distributed, or labeled by I Shay Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 2%..................... Topical Analgesic

Camphor 3%................... Topical Analgesic

PURPOSE

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.

KEEP OUT OF REACH OF CHILDREN

WARNINGS - Keep out of reach of children

INDICATIONS & USAGE

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. Cooling pain relief.

Inactive Ingredients

Ethanol, Water, Methyl Salicylate, Hydrogenated Castor Oil, FD&C Blue No. 1.

Warnings

For external use only

Avoid contact with eyes

Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not apply to wounds or damaged skin

Do not bandage tightly

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

DIRECTIONS

Adults ands children 2 years of age and older: Spray to affected area not more than 3 to 4 times daily. Leave it on.

Children under 2 years of age: Consult a physician

Other Information

Store at room temperature between 15 °and 30°C (59°-86°F)

label

INGREDIENTS AND APPEARANCE

HIELO MINERAL 
external analgesic liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65112-261
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.02 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.18 g  in 1 g
ALCOHOL (UNII: 3K9958V90M)	0.65 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65112-261-01	254 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		01/13/2021

Labeler - I Shay Cosmetics Inc (151582384)