FDA.reportPublic FDA data

Pharmacys Prescription Analgesic Gel

Manufacturer
American Consumer Products Corp
Effective date
2025-01-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:53:35

Label at a glance#

ProductPharmacys Prescription Analgesic Gel
Active ingredientMENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Menthol 1%

Purpose

OTC - PURPOSE SECTION

Purpose: Pain relieving gel

Warnings

WARNINGS SECTION

Warnings: For external use only

Stop Use

OTC - STOP USE SECTION

Stop use and ask doctor if

- condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

carbomer, isopropyl alcohol, nonyl phenyl polyoxyethylene ether, camphor, kathon CG, FD&C blue no. 1, triethanolamine, water

Indications & Usage Section

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - bruses - sprains

When using this product

- avoid contact with eyes

- do not bandage tightly

- do not apply to wounds or damaged skin

- do not use with heating pads or other heating devices

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions

- adults and childrent 2 years of age and older: apply to affected area not more than 3 to 4 times daily

- children under 2 years of age: do not use, consult a doctor

Pharmacy's Prescription 8 OZ Ice Cold Analgesic Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharmacys Prescription 8 OZ Ice Cold AnalgesicPharmacys Prescription 8 OZ Ice Cold Analgesic

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039043menthol 1 % Topical GelPSN4
1039043menthol 0.01 MG/MG Topical GelSCD4
1039043menthol 1 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72197-001-082023-05-09C16284748780-1f386c649-d426-0266-e053-dadaa90a7c1aPharmacy's Prescription 8OZ Ice Cold Analgesic Gel
72197-001-082023-01-30C16284748780-1f386c649-d426-0266-e053-dadaa90a7c1aPharmacy's Prescription 8OZ Ice Cold Analgesic Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72197-001-08Pharmacys Prescription Analgesic Gel227 g in 1 BOTTLE, PLASTICGEL2274

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72197-001PHARMACYS PRESCRIPTION ANALGESIC GEL (MENTHOL) GEL [AMERICAN CONSUMER PRODUCTS CORP]4Current NDC, Legacy NDC, 1 package rows20250125_6f0725f2-833f-f3a0-e053-2a91aa0a3911.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72197-00172197-001-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ISOPROPYL ALCOHOLND2M416302IACT
CAMPHOR, (-)-213N3S8275IACT
CARBOMER 9404Q93RCW27EIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
2,2',3,3',4,4',5,5',6-NONACHLORODIPHENYL ETHER4S0765P9W8IACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
WATER059QF0KO0RIACT

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
Pharmacys Prescription Analgesic GelMENTHOLAmerican Consumer Products Corp6f0725f2-833f-f3a0-e053-2a91aa0a39112025-01-23WarningsExact identifier
ndc (package): 72197-001-08
ndc (product): 72197-001
ndc11 (package): 72197000108
spl id: 2c69ab76-e3d1-1436-e063-6294a90aa515
spl set id: 6f0725f2-833f-f3a0-e053-2a91aa0a3911

Reported adverse events (FAERS/openFDA)#

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