Label: SNO SWEDISH ARCTIC GEL RECOVERY- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70316-360-02 - Packager: Natumin Pharma AB
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 18, 2015
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- Official Label (Printer Friendly)
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Drug Facts
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.
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
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
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INGREDIENTS AND APPEARANCE
SNO SWEDISH ARCTIC GEL RECOVERY
menthol gelProduct 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)