Active Ingredients
Menthol USP 12%
Camphor 6%
Anesthall Pain Relieving Cream
FDA Label NDC 84006-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Pharmaceutics Inc for the product Anesthall Pain Relieving Cream (NDC 84006-101). 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, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Methyl Salicylate 6.1%..................... External Analgesic
Menthol 4.6%....................................External Analgesic
Uses
for temporary relief of minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- Sprains
Warnings
For external use only
Otc - Do Not Use
Do not use
- on damaged or broken skin
Otc - When Using
When using this product
- do not bandage tightly
- avoid contact with eyes
Otc - Stop Use
Stop use and ask doctor if
- condition worses or if symptoms persist for more than 7 days, or clear up and occur again within a few days
- redness is present
- 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 immediately.
Directions
- Adults and children 2 years of age and older:Apply to affected area not more than 4 times daily
- Children under 2 years of age: Do Not Use
Other Information
- Store at 15-30C (59-86F) away from direct sunlight
Inactive Ingredients
Cetyl Alcohol, Dimethicone, Gentian Violet, Glyceryl Monostearate, Oil of Cajeput, Oil of Eucalyptus, Potassium Hydroxide, Propylene Glycol, Water, Sodium Borate, Sorbitan Sesquioleate, Stearic Acid, Thymol.
Package Label.Principal Display Panel
Anesthall
Pain Relieving Cream
Methyl Salicylate 6.1%
Menthol 4.6%
For temporary relief of minor aches and pains
Net Wt. 4 oz (113.5 g)
* Please review the disclaimer below.
