NDC | 76176-045-01 |
Set ID | 760be0f2-b5b2-b22a-e053-2991aa0a90d5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Ningbo Liyuan Daily Chemical Products Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- Drug Facts Active Ingredients:
Menthol 1 percent...............................................Topical Analgesic
Camphor 0.5 percent.........................................Topical Analgesic
Close - PURPOSE
- Uses:
for the temporary relief of minor aches and pains in muscles and joints associated with:
simple backache, strains, sprains, sports injuries, arthritis, bruises
Close - Warnings: External Use Only
- Do not use
- When using this product:
- 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,
- Keep out of reach of children.
- 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
Close - INGREDIENTS AND APPEARANCE
U ICE COLD
menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76176-045 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) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76176-045-01 227 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 - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098) Registrant - Ningbo Liyuan Daily Chemical Products Co., Ltd. (530766098) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan Daily Chemical Products Co., Ltd. 530766098 manufacture(76176-045)