Label: XTRACARE ICE COLD TOPICAL ANALGESIC GEL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-052-01, 58503-052-02 - Packager: China Ningbo Shangge Cosmetic Technology Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 6, 2018
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
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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)
