ARCTIC ICE- menthol gel 
BLUE CROSS LABORATORIES, INC.

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.

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ARCTIC ICE Pain Relieving Gel

Active Ingredient:

Menthol, 2 percentage

Purpose

Topical analgesic

Uses:

Temporarily relieves:

minor muscle aches and pains

Warnings:

For external use only; avoid contact with eyes. Ask a doctor before use if you have cough associated with

smoking, excessive phlegm, asthma, emphysema, persistent or chronic cough

When using this product, do not:

heat

microwave

add to hot water or any container where heating water may cause splattering 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

Consult a doctor and discontinue use:

if condition worsens, persists for more than 1 week or tends to recur.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DIRECTIONS:

For the temporary relief of minor muscle aches and pains.

See important warnings under "When using this product"

Inactive Ingredients:

Blue 1, Camphor, Carbomer, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, Water.

Arctic Ice Pain Relieving Gel

Fast acting Cooling Formula Greaseless

NET. WT. 6 oz. (170g)

6 oz ice

label

ARCTIC ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22431-022-01198 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/2020
2NDC:22431-022-02170 g in 1 BOTTLE; Type 0: Not a Combination Product05/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2020
Labeler - BLUE CROSS LABORATORIES, INC. (008298879)
Registrant - BLUE CROSS LABORATORIES, INC. (008298879)

Revised: 5/2022
Document Id: de5c637f-e96a-9ddc-e053-2995a90a0221
Set id: b3bc0291-c535-56a6-e053-2a95a90abc15
Version: 3
Effective Time: 20220506
 
BLUE CROSS LABORATORIES, INC.