Label: HEIBAITONG PAIN RELIEVING PATCH- menthol, camphor patch
Contains inactivated NDC Code(s)
NDC Code(s): 72328-001-01
- Packager: Harbin Kangyou Pharmaceutical Limited Company
- 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.
Updated December 11, 2018
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- ACTIVE INGREDIENTS
- Do not use
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- When using this product
- STOP USE AND ASK A DOCTOR IF
- Keep out of reach of children.
Adults and children 12 years of age and older: This product can be applied up to 168 hours of repeated uses. Remove the package from package. Heat up the patch until it easily gets separated and it becomes soft and glossy (avoid touching on skin when it is hot from the heat). Apply one or two patches to affected area once a day. Remove after every 6-12 hours depending on symptoms. During treatments, it is normal to feel the heat from patch itself. It can be removed anytime if discomfort occurs. Children 2 to 12 years of age and adults with compromised health: Use only under the guidance of a doctor. Children under 2 years of age: Do not use, consult a doctor. Refer to the above warnings: use otherwise than as directed may be dangerous.
- Other Information
NOTOPTERYGIUM INCISUM ROOT, ANGELICA PUBESCENS ROOT, SINOMENIUM ACUTUM STEM, PERIPLOCA SEPIUM ROOT BARK, SAPOSHNIKOVIA DIVARICATA ROOT, ATRACTYLODES LANCEA ROOT, CNIDIUM MONNIERI FRUIT, ALPINIA OFFICINARUM WHOLE, CUMINUM CYMINUM WHOLE, CINNAMON, ANGELICA SINENSIS ROOT, PAEONIA LACTIFLORA ROOT, PAPAYA, CAESALPINIA SAPPAN WOOD, RHUBARB, PINUS TABULIFORMIS BARK, DIPSACUS CHINENSIS WHOLE, LIGUSTICUM WALLICHII ROOT, ANGELICA DAHURICA ROOT, FRANKINCENSE OIL, MYRRH, BORNEOL, CLOVE OIL, CHINESE CINNAMON, CINNAMOMUM CASSIA TWIG, PANAX NOTOGINSENG ROOT, SAFFRON, ERYCIBE OBTUSIFOLIA STEM, PIPER KADSURA STEM, FOSSILIZED MAMMAL BONE
- Questions or Comments?
- Manufactured by Kangyou Pharmaceutical Limited Company2nd Building, 1st Floor, 8 Km Half of Ha Double Highway in Dao Li DistrictHarbin 150076, China
- Drug Facts
INGREDIENTS AND APPEARANCE
HEIBAITONG PAIN RELIEVING PATCH
menthol, camphor patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72328-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5.0 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.5 g in 100 g Inactive Ingredients Ingredient Name Strength NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI) ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ) SINOMENIUM ACUTUM STEM (UNII: BBH96IEM66) PERIPLOCA SEPIUM ROOT BARK (UNII: 638OW484M3) SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD) ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O) CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS) ALPINIA OFFICINARUM WHOLE (UNII: 6D24820XKG) CUMINUM CYMINUM WHOLE (UNII: 5BD8A7OW68) CINNAMON (UNII: 5S29HWU6QB) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P) PAPAYA (UNII: KU94FIY6JB) CAESALPINIA SAPPAN WOOD (UNII: 086263LQDD) RHUBARB (UNII: G280W4MW6E) PINUS TABULIFORMIS BARK (UNII: 3G75L8C3RU) DIPSACUS CHINENSIS WHOLE (UNII: O6JK1ZU9NN) LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS) ANGELICA DAHURICA ROOT (UNII: 1V63N2S972) FRANKINCENSE OIL (UNII: 67ZYA5T02K) MYRRH (UNII: JC71GJ1F3L) BORNEOL (UNII: M89NIB437X) CLOVE OIL (UNII: 578389D6D0) CHINESE CINNAMON (UNII: WS4CQ062KM) CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP) PANAX NOTOGINSENG ROOT (UNII: GQX1C1175U) SAFFRON (UNII: E849G4X5YJ) ERYCIBE OBTUSIFOLIA STEM (UNII: V1G1S38CQI) PIPER KADSURA STEM (UNII: 80IOP41EL7) MAMMAL BONE, FOSSILIZED (UNII: 0N1T3913DA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72328-001-01 1 in 1 POUCH 07/23/2018 1 13 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 07/23/2018 Labeler - Harbin Kangyou Pharmaceutical Limited Company (554409031) Registrant - Harbin Kangyou Pharmaceutical Limited Company (554409031) Establishment Name Address ID/FEI Business Operations Harbin Kangyou Pharmaceutical Limited Company 554409031 manufacture(72328-001)