GOLDEN SUNSHINE FAR INFRARED HOT HERBAL- topical analgesic patch 
Golden Sunshine International, Inc.

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Golden Sunshine Far Infrared HOT Herbal Patch

Topical Analgesic

Active Ingredients

Menthol 3% - Topical Analgesic, Wintergreen Oil 0.5% - Topical Analgesic

Indications

For the temporary relief of minor aches of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Directions

For adults and children 6 and older. Clean the affected area before use. Can be cut to size. Peel off film and cover affected area with patch. Keep on for up to 8 hours under normal conditions. Apply once or twice per day as needed. Allow skin to breath for a few hours between applications. Users with sensitive skin should test on a small area first.

Warnings

  • 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.
  • Avoid use on extremely hairy areas of the body as removal may remove hair.

  • If pregnant or breast feeding consult a doctor before use.

  • Keep out of reach of children.

Other Ingredients

Sesame oil, resin, nelumbinis stamin, zinc oxide, resina liquidambaris, frankencense, myrrha, angelicae sinensis radix, scrophulariae radix, gleditsiae abnormalis fructus, angelicae dahuricae radix, armeniacae amarum semen, tourmaline, tartrazine

For Questions or Comments Call:

1 (800) 798-3977

Golden Sunshine Far Infrared HOT Herbal Patch pouch for 3 patches.

GS HOT Patch LABEL for 3 patch Pouch.jpg

GOLDEN SUNSHINE FAR INFRARED HOT HERBAL 
topical analgesic patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67475-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.03 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV) .565 g  in 1 g
PINUS MASSONIANA RESIN (UNII: 64S07U83T7) .2 g  in 1 g
NELUMBO NUCIFERA STAMEN (UNII: 88637P8Y3U) .03 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) .03 g  in 1 g
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93) .02 g  in 1 g
FRANKINCENSE (UNII: R9XLF1R1WM) .02 g  in 1 g
MYRRH (UNII: JC71GJ1F3L) .02 g  in 1 g
ANGELICA SINENSIS ROOT (UNII: B66F4574UG) .014 g  in 1 g
SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R) .014 g  in 1 g
GLEDITSIA SINENSIS FRUIT (UNII: A6W0J6UO7Q) .014 g  in 1 g
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) .014 g  in 1 g
PRUNUS ARMENIACA SEED (UNII: 75356789IW) .014 g  in 1 g
SCHORL TOURMALINE (UNII: 173O8XLY6T) .01 g  in 1 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) .0001 g  in 1 g
Product Characteristics
ColoryellowScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67475-112-0150 in 1 BOX08/02/2004
13 in 1 POUCH
16 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:67475-112-0210 in 1 BAG08/02/2004
26 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:67475-112-0310 in 1 BAG08/02/2004
33 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/02/200412/26/2022
Labeler - Golden Sunshine International, Inc. (098930857)
Registrant - Golden Sunshine International, Inc. (098930857)
Establishment
NameAddressID/FEIBusiness Operations
Golden Sunshine International, Inc.098930857label(67475-112)

Revised: 11/2023
Document Id: b331d0c4-5632-4fb4-8289-8d79a5f411ed
Set id: f83c0e9d-9f59-48ce-9fc3-083ef619cbd8
Version: 3
Effective Time: 20231116
 
Golden Sunshine International, Inc.