Label: ARCTIC ICE- menthol gel
- NDC Code(s): 22431-022-01, 22431-022-02
- Packager: BLUE CROSS LABORATORIES, INC.
- 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.
Updated May 6, 2022
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- Active Ingredient:
- When using this product, do not:
- Consult a doctor and discontinue use:
- Keep out of reach of children.
For the temporary relief of minor muscle aches and pains.
See important warnings under "When using this product"
- not for use on children under 2 years of age
- adults & children 2 years & older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22431-022 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 METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER 934 (UNII: Z135WT9208) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:22431-022-01 198 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2020 2 NDC:22431-022-02 170 g in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2020 Labeler - BLUE CROSS LABORATORIES, INC. (008298879) Registrant - BLUE CROSS LABORATORIES, INC. (008298879)