Active Ingredients
Menthol 5%
Camphor 3.5%
Heibaitong Pain Relieving Patch
FDA Label NDC 72328-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Harbin Kangyou Pharmaceutical Limited Company for the product Heibaitong Pain Relieving Patch (NDC 72328-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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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