FDA.reportPublic FDA data

Anesthall Pain Relieving Cream

Manufacturer
Advanced Pharmaceutics Inc
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:06

Label at a glance#

ProductAnesthall Pain Relieving Cream
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure8 sections

Indications and uses

for temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises Sprains

Dosage and administration

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

Storage and handling

Store at 15-30C (59-86F) away from direct sunlight

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 12%

Camphor 6%

Purpose

OTC - PURPOSE SECTION

Methyl Salicylate 6.1%..................... External Analgesic

Menthol 4.6%....................................External Analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • Sprains

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • do not bandage tightly
  • avoid contact with eyes

OTC - STOP USE SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • Store at 15-30C (59-86F) away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

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 4 ozAnesthall 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)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84006-101-042025-07-29C16284748780-13b156c62-303d-fb37-e063-e6dba90a4e070c3e209e-0b5c-7794-e063-6294a90a8377

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84006-101-04Anesthall Pain Relieving Cream113.5 g in 1 TUBECREAM113.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84006-101ANESTHALL PAIN RELIEVING CREAM (METHYL SALICYLATE, MENTHOL) CREAM [ADVANCED PHARMACEUTICS INC]11 package rows20240113_0c3e209e-0b5c-7794-e063-6294a90a8377.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84006-10184006-101-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICONZ4152N8IUIIACT
METHYL SALICYLATELAV5U5022YACTIB
GENTIAN VIOLETJ4Z741D6O5IACT
SODIUM BORATE91MBZ8H3QOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
STEARIC ACID4ELV7Z65APIACT
THYMOL3J50XA376EIACT
EUCALYPTUS OIL2R04ONI662IACT
MELALEUCA VIRIDIFLORA FLOWERING TOPGC065MH3T2IACT
MENTHOLL7T10EIP3AACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c3e209e-0b5d-7794-e063-6294a90a83770c3e209e-0b5c-7794-e063-6294a90a83772024-01-11WarningsExact identifier
spl id: 0c3e209e-0b5d-7794-e063-6294a90a8377
spl set id: 0c3e209e-0b5c-7794-e063-6294a90a8377

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.