HEIBAITONG PAIN RELIEVING PATCH- menthol, camphor patch 
Harbin Kangyou Pharmaceutical Limited Company

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.

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Harbin Kangyou Pharmaceutical Limited Company

ACTIVE INGREDIENTS

Menthol       5%

Camphor     3.5%

PURPOSE

Menthol         External Analgesic

Camphor       External Analgesic

USES

For the temporary relief of minor aches and pains of muscles and joints due to: simple backache, arthritis, strains, bruises, sprains.

Warnings

For External Use only.

Do not use

on wounds.
on irritated or damaged skin.
if the appearance of this product has changed.
in excess of 12 hours.
if you are hypersensitive to this product.
otherwise than as directed.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

pregnant.
taking other medications.

When using this product

avoid contact with the eye or mucous membranes.
do not bandage tightly.
supervise use by children.
use caution if prone to allergic reactions.

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.
redness is present.
in conditions affecting children under 12 years of age.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Keep container tightly closed.
Store below 20 ℃ (68 ℉) in a dry area.

Inactive Ingredients

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?

Relief Saturated LLC
Alhambra, California 91801

Call (626) 247-0304 or
E-mail: kyle.hsieh18@gmail.com

Manufactured by

Kangyou Pharmaceutical Limited Company
2nd Building, 1st Floor, 8 Km Half of Ha Double Highway in Dao Li District
Harbin 150076, China

Distributed by

Relief Saturated LLC
Alhambra, California 91801 USA

Drug Facts

image description

HEIBAITONG PAIN RELIEVING PATCH 
menthol, camphor patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72328-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.0 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72328-001-011 in 1 POUCH07/23/2018
113 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/23/2018
Labeler - Harbin Kangyou Pharmaceutical Limited Company (554409031)
Registrant - Harbin Kangyou Pharmaceutical Limited Company (554409031)
Establishment
NameAddressID/FEIBusiness Operations
Harbin Kangyou Pharmaceutical Limited Company554409031manufacture(72328-001)

Revised: 12/2018
Document Id: 28a53b6f-d9a8-435b-bde0-c42fe088ef36
Set id: f13500bd-9357-42df-84fa-bf9924f9523e
Version: 32467
Effective Time: 20181211
 
Harbin Kangyou Pharmaceutical Limited Company