Label: SNO SWEDISH ARCTIC GEL SUPPORT- camphor, menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70316-320-02 - 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 January 2, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
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Warnings
For external use only
When using this product us only as directed
Read and follow all directions and warnings on this label
Rare cases of serious burns have been reported with products of this type
Do not bandage tightly or apply local heat (such as heating pads) or medicated patches to the area of use
Avoid contact with eyes and mucous membranes
Do not apply to wounds or damaged, broken or irritated skin
A transient burning sensation may occur upon applicaiton bu generally disappears in several days
- Stop use and ask doctor if
- If pregnant or breastfeeding
- Keep out of reach of children
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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 3 to 4 times daily, allowing a minimum of 2-3 hours between applications
After applying, wash hands with soap and water
Children 12 years or under, ask a doctor
- Other Information
- Inactive Ingredients
- Principle Display Panel- 100g Tube Carton
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INGREDIENTS AND APPEARANCE
SNO SWEDISH ARCTIC GEL SUPPORT
camphor, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70316-320 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 2.8 g in 100 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 2.25 g in 100 g Inactive Ingredients Ingredient Name Strength AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SUNFLOWER OIL (UNII: 3W1JG795YI) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70316-320-02 1 in 1 CARTON 1 100 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 01/02/2016 Labeler - Natumin Pharma AB (426847083) Registrant - Natumin Pharma AB (426847083) Establishment Name Address ID/FEI Business Operations Natumin Pharma AB 426847083 manufacture(70316-320)
