SNO SWEDISH ARCTIC GEL RECOVERY- menthol gel

Sno Swedish Arctic Gel Recovery by

Drug Labeling and Warnings

Sno Swedish Arctic Gel Recovery by is a Otc medication manufactured, distributed, or labeled by Natumin Pharma AB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol 2.25%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with

• simple backache
• muscle strains
• sprains
• bruises

Warning

For external use only

When using this product use only as directed

Do not bandage tightly or use with a heating pad

Avoid contact with eyes or mucous membranes

Do not apply to wounds or damaged skin.

Stop use and ask a doctor if

Condition worsens

Redness is present

Irritation develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast feeding,

ask a health professional before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

Apply a thin layer to affected area

Massage into painful area until thoroughly absorbed into skin

Repeat as necessary, but no more than 4 times daily

Children 12 years or younger: ask a doctor

Other Information

Store at 68-77°F (20-25°C).

Protect from excessive moisture.

Inactive Ingredients

Arnica montana flower extract

calendula officinalis extract

ethylhexylglycerin

fragrance

glycerin

helianthus annuus (sunflower) seed oil

hydrongenated polydecene

isostearyl isostearate

lauryl glucoside

neoruscogenin

phenoxyethanol

propylene glycol

ruscogenin

sodium acrylates/beheneth-25 methacrylate crosspolymer

water

Principle Display Panel- 75g tube carton

INGREDIENTS AND APPEARANCE

SNO SWEDISH ARCTIC GEL RECOVERY 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70316-360
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	2.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
RUSCOGENIN (UNII: BXI92R2VUJ)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70316-360-02	1 in 1 CARTON
1		75 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 not final	part348	12/18/2015

Labeler - Natumin Pharma AB (426847083)

Registrant - Natumin Pharma AB (426847083)

Establishment
Name	Address	ID/FEI	Business Operations
Natumin Pharma AB		426847083	manufacture(70316-360)