Personal CARE

Manufacturer
Delta Brands & Products LLC
Effective date
2018-04-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:15

Label at a glance#

ProductPersonal CARE ICE COLD ANALGESIC
Active ingredientMENTHOL
Label structure12 sections

Indications and uses

■ temporarily relieves minoraches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ strains ■ bruises ■ sports injuries ■ sprains ■ ​provides cooling penetrating relief

Dosage and administration

■ clean affected area before applying product ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25%

Purpose

OTC - PURPOSE SECTION


Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

■ temporarily relieves minoraches and pains of muscles and joints associated with:

■ arthritis ■ simple backache ■ strains ■ bruises ■ sports injuries ■ sprains ■ ​provides cooling penetrating relief

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ with other topical relievers ■ with heating pads or heating devices

When using this product

OTC - WHEN USING SECTION

■ do not use in or near the eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days ■ redness or irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ clean affected area before applying product ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

■ stroe at controlled room temperature 20 to 25 ºC (68 to 77ºF) in a tightly closed container ■ do not use, pour, spill or store near heat or open flame

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no. 1, isopropyl alcohol, PEG-40 hydrogenated castor oi, propylene glycol, sodium hydroxide, water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
866128menthol 1.25 % Topical GelPSN1
866128menthol 0.0125 MG/MG Topical GelSCD1
866128menthol 1.25 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72133-210-082025-07-29C16284748780-13b156c62-26a2-fb37-e063-e6dba90a4e076a37570e-c41b-d091-e053-2991aa0acbb9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72133-210-08Personal CAREICE COLD ANALGESIC227 g in 1 JARGEL2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72133-210PERSONAL CARE ICE COLD ANALGESIC (MENTHOL) GEL [DELTA BRANDS & PRODUCTS LLC]1Legacy NDC, 1 package rows20180419_6a37570e-c41b-d091-e053-2991aa0acbb9.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72133-21072133-210-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
6a37570e-c42d-d091-e053-2991aa0acbb96a37570e-c41b-d091-e053-2991aa0acbb92018-04-17WarningsExact identifier
spl id: 6a37570e-c42d-d091-e053-2991aa0acbb9
spl set id: 6a37570e-c41b-d091-e053-2991aa0acbb9

Reported adverse events (FAERS/openFDA)#

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