Label: PAIN TERMINATOR ANALGESIC- menthol and methyl salicylate cream
- NDC Code(s): 67475-313-01, 67475-313-02, 67475-313-03
- 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.
If you are a consumer or patient please visit this version.
- Active Ingredients
Menthol 2% - Topical Analgesic, Wintergreen Oil 0.5% - Topical AnalgesicClose
For the temporary relief of minor aches of muscles and joints associated with:
- simple backache
Apply to affected area not more than 2 to 3 times daily. Try on small area first to test forClose
sensitivity. Children under 4 years of age should not use, unless consulted by a physician.
- 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
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, tourmalineClose
- For Questions or Comments Call:
1 (800) 798-3977Close
- PAIN Terminator sleeve for 50g tube.
- INGREDIENTS AND APPEARANCE
PAIN TERMINATOR ANALGESIC
topical analgesic cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67475-313 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL .02 g in 1 g METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE .005 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67475-313-01 500 g in 1 JAR 2 NDC:67475-313-02 12 in 1 BOX 2 1 in 1 BOX 2 50 g in 1 TUBE 3 NDC:67475-313-03 5 g in 1 TUBE 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. <paragraph/></text> (098930857) Establishment Name Address ID/FEI Business Operations Golden Sunshine International, Inc. <paragraph/></text> 098930857 label(67475-313)