SNO SWEDISH ARCTIC GEL RECOVERY- menthol gel 
Natumin Pharma AB

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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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

sno Swedish Arctic Gel Recovery

SNO SWEDISH ARCTIC GEL RECOVERY 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70316-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70316-360-021 in 1 CARTON
175 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/18/2015
Labeler - Natumin Pharma AB (426847083)
Registrant - Natumin Pharma AB (426847083)
Establishment
NameAddressID/FEIBusiness Operations
Natumin Pharma AB426847083manufacture(70316-360)

Revised: 12/2015
Document Id: 271a556c-2760-2d15-e054-00144ff88e88
Set id: 271a556c-275f-2d15-e054-00144ff88e88
Version: 1
Effective Time: 20151218
 
Natumin Pharma AB