Label: ICE ANALGESIC- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 50438-501-01 - Packager: Filo America
- Category: HUMAN OTC DRUG LABEL
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 May 5, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ICE 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
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)
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INGREDIENTS AND APPEARANCE
ICE ANALGESIC
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50438-501 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.0 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:50438-501-01 227 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/05/2015 Labeler - Filo America (943873703) Registrant - Ningbo Pulisi Daily Chemical Products Co., Ltd. (529047265) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products Co., Ltd. 529047265 manufacture(50438-501)