Active Ingredients
Camphor 5.0%
Menthol 1.3%
Pain Relief Tincture
FDA Label NDC 42217-206
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henan Lingrui Pharmaceutical Co Ltd for the product Pain Relief Tincture (NDC 42217-206). 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
Camphor External Analgesic
Menthol 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 have known 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
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
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: Apply to affected area three times a day, 2 - 5ml each time, a course of 15 days.
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
ANGELICA SINENSIS ROOT, LIGUSTICUM WALLICHII ROOT, SAFFLOWER, ZANTHOXYLUM PIPERITUM WHOLE, KAEMPFERIA GALANGA WHOLE, CINNAMON, GREEN PEPPERCORN, CHINESE RHUBARB ROOT, LONG PEPPER, GINGER, CLOVE, BORNEOL, ETHANOL
Drug Facts
Carton (Carton)
Questions Or Comments?
E-mail: [email protected]
Manufactured By
Henan Lingrui Pharmaceutical Co.; Ltd.
232 Xiang Yang Road, Xin County, Henan, China
Beijing Lingrui Wellspring Imp. & Exp. Co.; Ltd.
Overseas Exclusive Distribution
* Please review the disclaimer below.
