Active Ingredients
Camphor 3.1%
Menthol 2.6%
Methyl Salicylate 2%
Pain Relieving Plaster
FDA Label NDC 81980-727
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Health Body World Supply Inc. for the product Pain Relieving Plaster (NDC 81980-727). 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, purposes, uses, warnings, keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
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
Allergy alert: this product contains natural rubber latex which may cause allergic reactions
Do not use
- on wounds
- on irritated or damaged skin if the appearance of this product has changed
- if you have known hypersensitivities to this product
- otherwise than as directed
- taking other medications
- pregnant
- avoid contact with the eyes or mucous membranes
- do not bandage tightly
- do not apply heat to the area in the form of heating
- pads, hot water bottles, or lamps (the risk of serious burns)
- avoid placing on extremely hairy areas of skin to avoid irritation upon removing the plaster
- 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:
Ask a doctor or pharmacist before use if you are
when using this product
Stop use and ask a doctor if
- 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 one or two plasters to affected area once a day. Remove after 12 hours.
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
Inactive Ingredients
Frankincense, Myrrh, Clove, Lindera Aggregata Root, Cinnamomi Cortex, Schizonepeta Bud, Saposhnikovia Divaricata Root, Geranium Wilfordii Top, Periploca Root Bark, Centella Asiatica, Drynaria Fortunei Root, Angelica Dahurica Root, Kaempferia Galanga Root, Ginger Root, Borneol, Latex Rubber, Rosin, Zinc Oxide, Petrolatum, Lanolin, Light Mineral Oil
* Please review the disclaimer below.
