ANESTHALL PAIN RELIEVING CREAM- methyl salicylate, menthol cream 
Advanced Pharmaceutics Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredients

Menthol USP 12%

Camphor 6%

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:

Warnings

For external use only

Do not use

  • on damaged or broken skin

When using this product

  • do not bandage tightly
  • avoid contact with eyes

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

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.

Anesthall 4 oz

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)

ANESTHALL PAIN RELIEVING CREAM 
methyl salicylate, menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84006-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SILICON (UNII: Z4152N8IUI)  
GENTIAN VIOLET (UNII: J4Z741D6O5)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
THYMOL (UNII: 3J50XA376E)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MELALEUCA VIRIDIFLORA FLOWERING TOP (UNII: GC065MH3T2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84006-101-04113.5 g in 1 TUBE; Type 0: Not a Combination Product01/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/11/2023
Labeler - Advanced Pharmaceutics Inc (926612636)

Revised: 1/2024
Document Id: 0c3e209e-0b5d-7794-e063-6294a90a8377
Set id: 0c3e209e-0b5c-7794-e063-6294a90a8377
Version: 1
Effective Time: 20240111
 
Advanced Pharmaceutics Inc