Otc - Active Ingredient
DRUG FACTS
Active Ingredients
Capsaicin ............ 0.1%
Neuronesic Pain Relieving Cream
FDA Label NDC 63347-999
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 Neuronesic Pain Relieving Cream (NDC 63347-999). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, 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
Otc - Purpose
Purpose ............... Topical Analgesic
Indications & Usage
USES ■ For temporary relief from minor aches and pains of sore
muscles and joints associated with arthritis pain, simple backache,
strains and sprains ■ Provides warming pain relief
Warnings
Warnings- for external use only
Do not use: ■ on wounds or damaged skin with a heating pad
■ if allergic to capsicum or chili peppers
When using this produc: ■
test on a small area of skin before
first use to check for skin sensitivity ■ avoid contact with eyes or
mucous membranes ■ do not bandage tightly ■ do not expose area
to direct heat or direct sunlight ■ a slight burning sensation may
occur upon application and generally disappears within several days
Stop use and ask a physician if: ■ condition worsens
■ redness is present ■ 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 (1-800-222-2222) immediately
Dosage & Administration
Directions
■
Adults and children 18 years of age and older:Apply to affected
area no more than 3 to 4 times daily. Wash hands with soap and
water after each use.
■
Children under 18 years of age:do not use, consult a physician.
Other Safety Information
Other Information
Store in a cool, dry place at 15°-30°C (59°-86°F).
Inactive Ingredient
Inactive Ingredients
Alkyl (C12-15) Benzoate, Caprylyl Glycol, Carica Papaya (Papaya)
Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol,
Dimethicone, Disodium EDTA, Emulsifying Wax, Ethylhexylglycerin,
Glycerin, Glyceryl Stearate, Hexylene Glycol, Hydrogenated
Polydecene, Hydroxyethyl Cellulose, PEG-100 Stearate,
Phenoxyethanol, Propylene Glycol, Purified Water, Sodium Lactate,
Sodium Polyacrylate, Trideceth-6, Xanthan Gum
Neuronesic Label
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BLAINE LABS DISPENSED EXCLUSIVELY BY PHYSICIANS
NeuroNesic™
PAIN-RELIEVING CREAM
INGREDIENTS INCLUDE
PROPRIETARY BLEND OF
PAPAYA EXTRACT AND
SAFFLOWER SEED OIL
3.0 0Z (85.0 g)
MANUFACTURED BY: Blaine Labs, Inc.
11037 Lockport Place, Santa Fe Springs, CA 90670
MADE IN THE U.S.A
QUESTIONS OR COMMENTS?
(800) 307-8818 M-F 7:30AM - 4:00PM (PST)
RES
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