Label: PAIN TERMINATOR ANALGESIC- menthol and methyl salicylate patch
- NDC Code(s): 67475-312-01, 67475-312-02
- 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 0.5% - Topical AnalgesicClose
For the temporary relief of minor aches of muscles and joints associated with:
- simple backache
- menstrual pain
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.Close
- 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.
- 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.Close
- For Questions or Comments Call:
1 (800) 798-3977Close
- PAIN Terminator pouch for 5 patches.
- INGREDIENTS AND APPEARANCE
PAIN TERMINATOR ANALGESIC
topical analgesic patch
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67475-312 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 .005 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Color brown Score Shape RECTANGLE Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67475-312-01 50 in 1 BOX 1 5 in 1 POUCH 1 3 g in 1 PATCH 2 NDC:67475-312-02 10 in 1 BAG 2 3 g in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/18/2006 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(67475-312)