NDC | 58503-052-01, 58503-052-02 |
Set ID | a76f6abe-37cf-459f-96e3-7dd60b6d5723 |
Category | HUMAN OTC DRUG LABEL |
Packager | China Ningbo Shangge Cosmetic Technology Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only. Avoid contact with eyes.
Ask a doctor before use if you have cough associated with
- smoking
- excessive phlegm
- asthma
- emphysema
- persistent or chronic cough
When using this product do not
- heat
- microwave
- add to hot water or any container where heating water may cause splattering and result in burns
- use in eyes or directly on mucous membranes
- take by mouth or place in nostrils
- apply to wounds or damaged skin
- bandage skin
Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
XTRACARE ICE COLD TOPICAL ANALGESIC GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3 g in 227 g Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-052-01 227 g in 1 BOTTLE; Type 0: Not a Combination Product 01/30/2014 2 NDC:58503-052-02 227 g in 1 TUBE; Type 0: Not a Combination Product 01/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/30/2014 Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-052)