Your browser does not support JavaScript! PAIN TERMINATOR ANALGESIC (TOPICAL ANALGESIC) CREAM [GOLDEN SUNSHINE INTERNATIONAL, INC.]
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PAIN TERMINATOR ANALGESIC (topical analgesic) cream
[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 2% - 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

Apply to affected area not more than 2 to 3 times daily. Try on small area first to test for
sensitivity. Children under 4 years of age should not use, unless consulted by a physician.

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.
  • In case of ingestion, seek professional assistance or contact a Poison Control Center immediately.

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

  • Keep out of reach of children.

Other Ingredients

Jojoba oil, paeonia veitchii radix, angelicae sinensis radix, carthami flos, pyritum, draconis resina, myrrha, ligustici rhizoma, acanthopanacis cortex, achyranthis radix, atractylodis rhizoma, gentianae macrophyllae radix, pinelliae tuber, saussureae radix, cnidii monnieri fructus, cinnamonomi cortex, dioscoreae tokoro rhizoma, jasmine oil, tourmaline

For Questions or Comments Call:

1 (800) 798-3977

PAIN Terminator sleeve for 50g tube.

PT Cream Sleeve for 50g Tube.jpg

PAIN TERMINATOR ANALGESIC 
topical analgesic cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67475-313
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL.02 g  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL.75 g  in 1 g
PAEONIA VEITCHII ROOT.04 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
MYRRH.02 g  in 1 g
LIGUSTICUM SINENSE ROOT.015 g  in 1 g
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK.1 g  in 1 g
ACHYRANTHES BIDENTATA ROOT.01 g  in 1 g
ATRACTYLODES JAPONICA ROOT.01 g  in 1 g
GENTIANA MACROPHYLLA ROOT.006 g  in 1 g
PINELLIA TERNATA ROOT.006 g  in 1 g
SAUSSUREA COSTUS ROOT.006 g  in 1 g
CNIDIUM MONNIERI FRUIT.006 g  in 1 g
CHINESE CINNAMON.005 g  in 1 g
DIOSCOREA JAPONICA TUBER.005 g  in 1 g
JASMINUM OFFICINALE FLOWER.003 g  in 1 g
SCHORL TOURMALINE.003 g  in 1 g
FD&C BLUE NO. 2.0001 g  in 1 g
FD&C YELLOW NO. 5.0001 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67475-313-01500 g in 1 JAR
2NDC:67475-313-0212 in 1 BOX
21 in 1 BOX
250 g in 1 TUBE
3NDC:67475-313-035 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/23/2009
Labeler - Golden Sunshine International, Inc. (098930857)
Registrant - Golden Sunshine International, Inc. <paragraph/></text> (098930857)
Establishment
NameAddressID/FEIBusiness Operations
Golden Sunshine International, Inc. <paragraph/></text>098930857label(67475-313)

Revised: 4/2013
 
Golden Sunshine International, Inc.

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