Label: GOLDEN SUNSHINE FAR INFRARED HERBAL- menthol and methyl salicylate paste
- NDC Code(s): 67475-211-01, 67475-211-02, 67475-211-03, 67475-211-04
- Packager: Golden Sunshine International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredients
Menthol 3% - Topical Analgesic, Wintergreen Oil 3% - Topical AnalgesicClose
For the temporary relief of minor aches of muscles and joints associated with:
- simple backache
Apply generous amount to clean, dry affected area. Cover with gauze 15-20 hours/day. Try on small area first to test for sensitivity. Children under 6 years of age should not use unless consulted by a physician.Close
- FOR EXTERNAL USE ONLY
- Avoid contac with eyes or mucous membranes.
- Do not apply to wounds or damaged or irritated skin.
- Do not use if skin is sensitive, or have allergies to any ingredients in this product. Discontinue use and consult a doctor if signs of irritation or rash appear.
- In case of ingestion, seek professional assistance or contact a Poison Control Center immediately.
- Other Ingredients
Sesame oil, resin, zinc oxide, tourmaline, amperopsis radix, angelicae dahuricae radix, angelicae sinensis radix, cinnamonomi cortex, momordicae semen, paeonia veitchii radix, notopterygium rhizoma, lindera radix, glycyrrhizae radix, angelica tuhon radix, scrophulariae radix, rhei rhizoma, rehmaniae radix et rhizoma, sophorae radix, indigo carmine, tartrazine.Close
- For Questions or Comments Call:
1 (800) 798-3977Close
- Golden Sunshine Far Infrared Herbal Paste 1200g Jar Label
- INGREDIENTS AND APPEARANCE
GOLDEN SUNSHINE FAR INFRARED HERBAL
topical analgesic paste
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67475-211 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL .03 g in 1 g METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE .03 g in 1 g Inactive Ingredients Ingredient Name Strength SESAME OIL .731 g in 1 g PINUS MASSONIANA RESIN .1 g in 1 g ZINC OXIDE .03 g in 1 g SCHORL TOURMALINE .01 g in 1 g AMPELOPSIS JAPONICA ROOT .005 g in 1 g ANGELICA DAHURICA ROOT .005 g in 1 g ANGELICA SINENSIS ROOT .005 g in 1 g CHINESE CINNAMON .005 g in 1 g MOMORDICA COCHINCHINENSIS SEED .005 g in 1 g PAEONIA VEITCHII ROOT .005 g in 1 g NOTOPTERYGIUM INCISUM ROOT .005 g in 1 g LINDERA AGGREGATA ROOT .005 g in 1 g GLYCYRRHIZA INFLATA ROOT .005 g in 1 g ANGELICA ACUTILOBA ROOT .005 g in 1 g SCROPHULARIA NINGPOENSIS ROOT .005 g in 1 g RHEUM OFFICINALE ROOT .005 g in 1 g REHMANNIA GLUTINOSA ROOT .005 g in 1 g SOPHORA FLAVESCENS ROOT .005 g in 1 g FD&C BLUE NO. 2 .0001 g in 1 g FD&C YELLOW NO. 5 .0001 g in 1 g Product Characteristics Color black Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67475-211-01 1200 g in 1 JAR 2 NDC:67475-211-02 300 g in 1 JAR 3 NDC:67475-211-03 450 g in 1 JAR 4 NDC:67475-211-04 35 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/23/2009 Labeler - Golden Sunshine International, Inc. (098930857) Registrant - Golden Sunshine International, Inc. (098930857) Establishment Name Address ID/FEI Business Operations Golden Sunshine International, Inc. 098930857 label(67475-211)