Label: REXALL ICE COLD ANALGESIC- menthol gel
- NDC Code(s): 55910-088-08
- Packager: Dolgencorp, LLC
- 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 October 4, 2018
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- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
REXALL ICE COLD ANALGESIC
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-088 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CUPRIC SULFATE (UNII: LRX7AJ16DT) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) THYMOL (UNII: 3J50XA376E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ISOPROPYL ALCOHOL (UNII: ND2M416302) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-088-08 227 g in 1 JAR; Type 0: Not a Combination Product 10/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2018 Labeler - Dolgencorp, LLC (068331990)