U ICE COLD- menthol ointment 
Ningbo Liyuan Daily Chemical Products Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by 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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Drug Facts
Active Ingredients:

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

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

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:

Stop use and ask Doctor if:

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

Inactive Ingredients:

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

1

U ICE COLD 
menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-0.5 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
WATER (UNII: 059QF0KO0R)  
METHYL ALCOHOL (UNII: Y4S76JWI15)  
CARBOMER 934 (UNII: Z135WT9208)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76176-045-01227 g in 1 TUBE; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2018
Labeler - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(76176-045)

Revised: 8/2018
Document Id: 760be0f2-b5b3-b22a-e053-2991aa0a90d5
Set id: 760be0f2-b5b2-b22a-e053-2991aa0a90d5
Version: 1
Effective Time: 20180801
 
Ningbo Liyuan Daily Chemical Products Co., Ltd.