Active Ingredients
Methyl Salicylate 20.7%
Menthol 15.6%
Camphor 3.1%
Herbal Balm Cream
FDA Label NDC 82198-0007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Big 5 Nutrition Llc for the product Herbal Balm (NDC 82198-0007). 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, otc - do not use, otc - when using, otc - stop use, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
For temporary relief of minor aches and pains of muscles and joints due to:
- arthritis
- strains
- bruises
- sprains
- simple backache
Warnings
For external use only
Otc - Do Not Use
Do not use
on wounds
irritated or damaged skin
sensative skin
with a heating pad
if pregnant
with, or as the same time as, other external analgesic products
if allergic to aspirin or salicylates
if allergic to any ingredients of this prodcut
Otc - When Using
When using this product
- avoid contact with eyes
- do not bandage tightly
- do not apply to wounds or damaged skin
- do not use 1 hour before or after bathing
Otc - Stop Use
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
- side effects occur
Other
If pregnant, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children to avoid accidental poisoning
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use otherwise than as directed.
Directions
- Apply to the affected area. Rub well on affected area.
- Repeat 2 times daily.
- Children under 2 years of age: Do not use or consult a doctor.
Other Information
- Store at room temperature, 20 to 25°C (68 to 77°F)
Other Ingredients
Eucalyptus Oil, Lavender Oil, Vaseline, White beeswax.
Questions Or Comments?
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Web: tnduocthao.com
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Label (Herbal Balm)
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