Your browser does not support JavaScript! PAIN TERMINATOR ANALGESIC (TOPICAL ANALGESIC) PATCH [GOLDEN SUNSHINE INTERNATIONAL, INC.]
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PAIN TERMINATOR ANALGESIC (topical analgesic) patch
[Golden Sunshine International, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

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
  • menstrual pain

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. For menstrual pain, place on abdomen. 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 contact 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, paeoniae veitchii radix, zinc oxide, drynariae rhizoma, angelicae sinensis radix, carthami flos, pyritum, draconis resina, frankencense, myrrha, terebinthina, ligustiei rhizoma, achyranthis radix, acanthopanacus cortex, acori rhizoma, atractylodis rhizoma, tourmaline, saussureae radix, gentianae macrophyllae radix, cnidii monnieri fructus, cinnamomum cortex, aconiti tuber, pinelliae tuber, dendrobii caulis, dioscoreae tokoro rhizoma, indigo carmine, tartrazine.

For Questions or Comments Call:

1 (800) 798-3977

PAIN Terminator pouch for 5 patches.

Pouch for PAIN Terminator Patches.jpg

PAIN TERMINATOR ANALGESIC 
topical analgesic patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67475-312
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL.03 g  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SESAME OIL.471 g  in 1 g
PINUS MASSONIANA RESIN.15 g  in 1 g
PAEONIA VEITCHII ROOT.04 g  in 1 g
ZINC OXIDE.03 g  in 1 g
DRYNARIA FORTUNEI ROOT.02 g  in 1 g
ANGELICA SINENSIS ROOT.02 g  in 1 g
CARTHAMUS TINCTORIUS FLOWER BUD.02 g  in 1 g
PYRITIDIUM.02 g  in 1 g
DAEMONOROPS DRACO RESIN.02 g  in 1 g
FRANKINCENSE.02 g  in 1 g
MYRRH.02 g  in 1 g
LARIX DECIDUA RESIN.02 g  in 1 g
LIGUSTICUM SINENSE ROOT.016 g  in 1 g
ACHYRANTHES BIDENTATA ROOT.01 g  in 1 g
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK.01 g  in 1 g
ACORUS CALAMUS ROOT.01 g  in 1 g
ATRACTYLODES JAPONICA ROOT.01 g  in 1 g
SCHORL TOURMALINE.01 g  in 1 g
SAUSSUREA COSTUS ROOT.006 g  in 1 g
GENTIANA MACROPHYLLA ROOT.006 g  in 1 g
CNIDIUM OFFICINALE ROOT.006 g  in 1 g
CHINESE CINNAMON.006 g  in 1 g
ACONITUM CARMICHAELII ROOT.006 g  in 1 g
PINELLIA TERNATA ROOT.006 g  in 1 g
DENDROBIUM NOBILE STEM.006 g  in 1 g
TOKORO YAM.006 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
ColorbrownScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67475-312-0150 in 1 BOX
15 in 1 POUCH
13 g in 1 PATCH
2NDC:67475-312-0210 in 1 BAG
23 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/18/2006
Labeler - Golden Sunshine International, Inc. (098930857)
Registrant - Golden Sunshine International, Inc. (098930857)
Establishment
NameAddressID/FEIBusiness Operations
Golden Sunshine International, Inc.098930857label(67475-312)

Revised: 4/2013
 
Golden Sunshine International, Inc.

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