Label: ICE COLD TOPICAL ANALGESIC GEL- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-3007-1 - Packager: Greenbrier International, Inc.
- 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 April 16, 2019
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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
- microwafe
- add to hot water or any container where healing 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 worsesn, persists for more than 1 week or tends to recur.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ICE COLD TOPICAL ANALGESIC GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-3007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.84 mg in 227 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) CAMPHOR (NATURAL) (UNII: N20HL7Q941) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-3007-1 237 mg in 1 BOTTLE; Type 0: Not a Combination Product 05/24/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/24/2013 Labeler - Greenbrier International, Inc. (610322518) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(33992-3007)