U ICE COLD- menthol ointment

U ICE COLD by

Drug Labeling and Warnings

U ICE COLD by is a Otc medication manufactured, distributed, or labeled by UNIVERSAL DISTRIBUTION CENTER LLC, Ningbo Liyuan Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Active Ingredients:

Menthol 1 percent...............................................Topical Analgesic

Camphor 0.5 percent.........................................Topical Analgesic

PURPOSE

Topical Analgesic

Uses:

for the temporary relief of minor aches and pains in muscles and joints associated with:

simple backache, strains, sprains, sports injuries, arthritis, bruises

Warnings: External Use Only

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 eyes
• Do not apply to wounds or damaged skin
• Do not bandage tightly

Stop use and ask 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 Posion Control Center immediately.

Directions

• clean affected area before applying products
• adults and children 2 years of age and older
• apply to affected area not more than 3 to 4 times daily

Inactive Ingredients:

Water(Aqua), Ethyl Alcohol, Carbomer, Methylchloroisothiazolinone, Methylisothiazolinone, Triethanolamine, FD&C Blue No. 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

U ICE COLD 
menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275)	CAMPHOR, (-)-	0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)
WATER (UNII: 059QF0KO0R)
METHYL ALCOHOL (UNII: Y4S76JWI15)
CARBOMER 934 (UNII: Z135WT9208)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-045-01	227 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2018

Labeler - UNIVERSAL DISTRIBUTION CENTER LLC (019180459)

Registrant - UNIVERSAL DISTRIBUTION CENTER LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(52000-045)