![PAIN TERMINATOR ANALGESIC (TOPICAL ANALGESIC) CREAM [GOLDEN SUNSHINE INTERNATIONAL, INC.]](https://medic.hrt.org//dailymed/images/ac38f9bd-6360-494c-b50d-5c5632743b91/PT Cream Sleeve for 50g Tube.jpg)
| NDC | 67475-313-01, 67475-313-02, 67475-313-03 |
| Set ID | ac38f9bd-6360-494c-b50d-5c5632743b91 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Golden Sunshine International, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART348 |
- PURPOSE
- Active Ingredients
- Indications
- Directions
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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.
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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:
- PAIN Terminator sleeve for 50g tube.
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INGREDIENTS AND APPEARANCE
PAIN TERMINATOR ANALGESIC
topical analgesic creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67475-313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL .02 g in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE .005 g in 1 g Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) .75 g in 1 g PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V) .04 g in 1 g ANGELICA SINENSIS ROOT (UNII: B66F4574UG) .02 g in 1 g CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0) .02 g in 1 g PYRITIDIUM (UNII: 0PFV70949S) .02 g in 1 g DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU) .02 g in 1 g MYRRH (UNII: JC71GJ1F3L) .02 g in 1 g LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO) .015 g in 1 g ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB) .1 g in 1 g ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1) .01 g in 1 g ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU) .01 g in 1 g GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B) .006 g in 1 g PINELLIA TERNATA ROOT (UNII: G9AET085M5) .006 g in 1 g SAUSSUREA COSTUS ROOT (UNII: RUP970CGR9) .006 g in 1 g CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS) .006 g in 1 g CHINESE CINNAMON (UNII: WS4CQ062KM) .005 g in 1 g DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356) .005 g in 1 g JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) .003 g in 1 g SCHORL TOURMALINE (UNII: 173O8XLY6T) .003 g in 1 g FD&C BLUE NO. 2 (UNII: L06K8R7DQK) .0001 g in 1 g FD&C YELLOW NO. 5 (UNII: I753WB2F1M) .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; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 02/23/2009 2 NDC:67475-313-02 12 in 1 BOX 02/23/2009 2 1 in 1 BOX 2 50 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:67475-313-03 5 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 02/23/2009 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)
