PERSONAL CARE ICE COLD- menthol gel

PERSONAL CARE ICE COLD by

Drug Labeling and Warnings

PERSONAL CARE ICE COLD by is a Otc medication manufactured, distributed, or labeled by NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 1.25%

Purpose

Topical analgesic

Uses

temporarily relieves minor muscle aches and pains of muscles and joints associated with:

arthritis, simple backache, strains, bruises, sports injuries, sprains, provides cooling penetrating relief

Warnings

For external use only.

Do not use: with other topical pain relievers, with heating pads or heating devices.

When using this product

do not use in or near the eyes.

do not apply to wounds or damaged skin.

do not bandage tightly.

Stop use and ask a doctor if

condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, redness or irritation develops.

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

clean affected area before applying product.

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

chidlren under 2 years of age: ask a doctor.

Other information

store at controlled room temperature 20 to 25℃ (68 to 77°F) in a tightly closed container.

do not use, pour, spill or store near heat or open flame.

Inactive ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PERSONAL CARE ICE COLD 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76176-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOMER 934 (UNII: Z135WT9208)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76176-021-01	227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2017

Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)