U ICE COLD: Package Insert and Label Information

U ICE COLD- camphor, (-)- and menthol ointment
UNIVERSAL DISTRIBUTION CENTER LLC

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.

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:

  • 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

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(click image for full-size original)

U ICE COLD
menthol ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-045
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR, (-)- (CAMPHOR, (-)-) CAMPHOR, (-)- 0.5 g in 100 g
MENTHOL (MENTHOL) MENTHOL 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
TRIETHANOLAMINE BENZOATE
WATER
METHYL ALCOHOL
CARBOMER 934
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52000-045-01 227 g in 1 TUBE None
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 Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd. 530766098 manufacture (52000-045)

Revised: 08/2018 UNIVERSAL DISTRIBUTION CENTER LLC

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