FDA Label for Heibaitong Pain Relieving Patch

View Indications, Usage & Precautions

Heibaitong Pain Relieving Patch Product Label

The following document was submitted to the FDA by the labeler of this product Harbin Kangyou Pharmaceutical Limited Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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. Apply one or two patches to affected area once a day. Remove after every 6-12 hours depending on symptoms. 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 (949)630-5682 or
E-mail: [email protected]


Manufactured Bykangyou Pharmaceutical Limited Company2nd Building, 1St Floor, 8 Km Half Of Ha Double Highway In Dao Li Districtharbin 150076, China



Distributed by

Relief Saturated LLC
Alhambra, California 91801 USA


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