Drug Facts
Active Ingredients
Menthol - 3.5%
Camphor - 3.0%
Orthonesic Pain Relieving Gel
FDA Label NDC 63347-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Blaine Labs Inc. for the product Orthonesic Pain Relieving Gel (NDC 63347-420). 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 drug facts, purpose, uses, warnings - for extrenal use only, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol - Topical Analgesic
Camphor - Topical Analgesic
Uses
■ For temporary relief from minor aches and pains of
muscles and joints associated with arthritis, bruises, strains
simple backache, and sprains.
Warnings - For Extrenal Use Only
Do not use: ■ on wounds or damaged skin ■ with a heating pad
When using this product: ■ avoid contact with eyes or mucous
membranes ■ do not bandage tightly
Stop use and ask a physician if: ■ condition worsens ■ symptoms
persist for more than 7 days or clear up and occur again within a
few days ■ excessive skin irritation develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help
or contact a Poison Control Center (1-800-222-1222) immediately
Flammable:Keep away from excessive heat or open flame
Dosage & Administration
Directions: Apply to the affected areas not more than 3 to 4 times daily. Rinse hands with cool water.
■ Adults and children 2 years and older:A pply to affected
area not more than 3 to 4 times daily.
■ Children under 2 years of age: do not use, consult a physician.
Other Safety Information
Other Information
Store in a cool, dry area at 15°-30° C(59°-86°F).
Inactive Ingredient
Inactive Ingredients: Aminomethylpropanol, Camellia Sinensis (Green Tea) Leaf Extract,
Capsicum Annum/Frutescens Fruit Extract, Carbomer, Ethyl
Alcohol, FD&C Blue #1, FD&C Yellow #5, Ilex Praguariensis
(Yerba Mate) Leaf Extract, Isopropyl Alcohol, Purified Water
Blaine Labs Ortho-Nesic Pain-Relieving-Gel - Labeling
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BLAINE LABS
ORTHO-NESIC
PAIN-RELIEVING-GEL
Menthol and Camphor
4.0 OZ (170 g)
MANUFACTURED BY:
Blaine Labs, Inc.
11037 Lockport Place
Santa Fe Springs, CA 90870
BLAINE LABS
RES
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