Label: ASTONEA COLD ICE ANALGESIC GEL- menthol gel
- NDC Code(s): 77338-402-12
- Packager: ASTONEA LABS PRIVATE LIMITED
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 25, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
- Warnings
- When using this product
- Stop use and ask a doctor if
- If pregnant or breastfeeding
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASTONEA COLD ICE ANALGESIC GEL
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77338-402 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.54 g in 227 g Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) ISOPROPYL ALCOHOL (UNII: ND2M416302) CUPRIC SULFATE (UNII: LRX7AJ16DT) THYMOL (UNII: 3J50XA376E) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77338-402-12 227 g in 1 JAR; Type 0: Not a Combination Product 04/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 04/08/2019 Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)