ARCTIC RELIEF- menthol, unspecified form gel

ARCTIC RELIEF by

Drug Labeling and Warnings

ARCTIC RELIEF by is a Otc medication manufactured, distributed, or labeled by STRATUS PHARMACEUTICALS INC, TARMAC PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Natural Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Inactive Ingredients

Camphor, carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, silicon dioxide, trolamine and purified water.

Uses

Temporary relief from minor aches and pains of sore muscles & joints associated with

• arthritis
• backache
• strains
• sprains.

Warnings

FOR EXTERNAL USE ONLY.

Flammable: Keep away from excessive heat or open flame.

Ask a doctor before use if you have sensitive skin.

When Using This Product

• Avoid contact with the eyes or mucous membranes
• Do not apply to wounds or damaged skin
• Do not use with other ointments, creams, sprays or liniments
• Do not apply to irritated skin or if excessive irritation develops
• Do not bandage
• Wash hands after use with cool water
• Do not use with a heating pad or device.

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
• Children under 2 years of age: Consult physician

Other Information

Store in a cool dry place with cap closed tightly

Questions or Comments?

Call Customer Service at 800-442-7882

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Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 113.4 gram Tube Box

Arctic Relief
PAIN RELIEVING GEL

NDC: 58980-615-40

Net WT. 4 oz. / 113.4 grams

GREASELESS STAINLESS VANISHING SCENT

PENETRATING, LONG-LASTING PAIN RELIEF FROM:
ARTHRITIS, SORE MUSCLES & JOINTS AND BACK PAIN.

STRATUS
PHARMACEUTICALS INC

INGREDIENTS AND APPEARANCE

ARCTIC RELIEF 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3.969 g  in 113.4 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58980-615-40	1 in 1 BOX	09/15/2017
1		113.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/15/2017

Labeler - STRATUS PHARMACEUTICALS INC (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
TARMAC PRODUCTS INC		059890491	MANUFACTURE(58980-615) , LABEL(58980-615) , PACK(58980-615)