Label: TONG FENG DING PAIN RELIEF- camphor and menthol patch
- NDC Code(s): 69070-301-01
- Packager: Zhejiang Dingtai Pharmaceutical Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: 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 Information
Updated February 4, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR/PHARMACIST
-
WHEN USING
When using this product
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)
■ avoid placing on extremely hairy areas of skin to avoid irritation upon removing the patch -
STOP USE
Stop use and ask a doctor if
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation of the skin develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
■ when using for pain of arthritis:
■ pain persists for more than 10 days
■ redness is present
■ in conditions affecting children under 12 years of age - ADVERSE REACTIONS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients
Alisma plantago-aquatica root (ze xie), butylated hydroxytoluene, corydalis yanhusuo tuber (yan hu suo), cyathula officinalis root (chuan niu xi), gentiana macrophylla root (qin jiao), lanolin, light mineral oil, natural latex rubber, paeonia veitchii root (chi shao), petrolatum, phellodendron chinensis bark (huang bai), plantago asiatica seed (che qian zi), rosin, smilax glabra tuber (tu fu ling), zinc oxide. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TONG FENG DING PAIN RELIEF
camphor and menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69070-301 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.10 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.60 g in 100 g Inactive Ingredients Ingredient Name Strength ALISMA PLANTAGO-AQUATICA ROOT (UNII: 6DXR2088WL) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CORYDALIS YANHUSUO TUBER (UNII: 0TUP42692Z) CYATHULA OFFICINALIS ROOT (UNII: BRM37UP34O) GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V) PETROLATUM (UNII: 4T6H12BN9U) PHELLODENDRON CHINENSIS BARK (UNII: 2866QMZ434) PLANTAGO ASIATICA SEED (UNII: YN3672Y65C) ROSIN (UNII: 88S87KL877) SMILAX GLABRA TUBER (UNII: PES3YXA3LR) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69070-301-01 2 in 1 BOX 01/31/2019 1 5 in 1 POUCH 1 1 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/31/2019 Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(69070-301)