ARCTIC ICE- menthol gel 
PRIMAL ELEMENTS

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Active Ingredient:

Menthol, 1.25%

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, Ethyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, Water.

label

ARCTIC ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80801-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER 934 (UNII: Z135WT9208)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80801-105-01198 g in 1 JAR; Type 0: Not a Combination Product10/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/01/2023
Labeler - PRIMAL ELEMENTS (968334144)

Revised: 10/2023
Document Id: 0794de46-c4ba-9299-e063-6394a90aab5d
Set id: 0794df09-8085-aadf-e063-6394a90af3ea
Version: 1
Effective Time: 20231013
 
PRIMAL ELEMENTS