Label: ASSURED ICE COLD TOPICAL ANALGESIC- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 33992-7994-8 - 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 March 27, 2013
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- Official Label (Printer Friendly)
- ASSURED ICE COLD TOPICAL ANALGESIC GEL
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product do not
- Consult a doctor and discontinue use
- Keep out of reach of children.
- Directions
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)
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INGREDIENTS AND APPEARANCE
ASSURED ICE COLD TOPICAL ANALGESIC
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-7994 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g in 100 g Inactive Ingredients Ingredient Name Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) ALCOHOL (UNII: 3K9958V90M) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33992-7994-8 227 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/06/2011 Labeler - Greenbrier International, Inc. (610322518) Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956) Establishment Name Address ID/FEI Business Operations Ningbo Unichem Household Products Co., Ltd. 528196956 manufacture(33992-7994)