Label: ARCTIC ICE ANALGESIC- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 22431-600-01 - Packager: Blue Cross Labs
- 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 January 27, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings: For external use only; avoid contact with eyes. Ask a doctor before use if you have associated with
- smoking
- excessive phlegm
- asthma
- emphysema
- persisten or chronic cough
When using this product, do; heat
- microwave
- add to hot water or any container where healing water may cause splatter and result in burns
- use in eyes or directly on mucous membranes
- take by mouth or place in nostrils
- apply to wounds or damaged skin
- bandage skin
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DOSAGE & ADMINISTRATION
Directions:
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 year & older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 time daily.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARCTIC ICE ANALGESIC
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22431-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER 940 (UNII: 4Q93RCW27E) ISOPROPYL ALCOHOL (UNII: ND2M416302) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:22431-600-01 227 g in 1 JAR; Type 0: Not a Combination Product 09/16/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/16/2015 Labeler - Blue Cross Labs (008298879) Registrant - Blue Cross Labs (008298879) Establishment Name Address ID/FEI Business Operations Blue Cross Labs 008298879 manufacture(22431-600)