ARCTIC ICE by PRIMAL ELEMENTS ARCTIC ICE- menthol gel

ARCTIC ICE by

Drug Labeling and Warnings

ARCTIC ICE by is a Otc medication manufactured, distributed, or labeled by PRIMAL ELEMENTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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"

• 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:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARCTIC ICE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80801-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80801-105-01	198 g in 1 JAR; Type 0: Not a Combination Product	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/01/2023

Labeler - PRIMAL ELEMENTS (968334144)