Quality Choice Cold Therapy Gel

Manufacturer
Chain Drug Marketing Association, Inc. | Astonea Labs Private Label
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:34

Label at a glance#

ProductQuality Choice Cold Therapy Gel
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis backache strains sprains

Dosage and administration

adults and children 2 years of age and older: rub a thin film over affected area not more than 4 times daily, massage is not necessary children under 2 years of age: consult a physician

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

sensitive skin

When using this product:

OTC - WHEN USING SECTION

■ avoid contact with eyes or mucous membranes

■ do not apply to wounds or damaged skin

■ do not use with other ointments, creams, sprays or liniments

■ do not apply to irritated skin or if excessive irritation develops

■ do not bandage ■ wash hands after use with cool water

■ do not use with a heating pad or device

Stop use an ask a doctor if

OTC - STOP USE SECTION

condition worsens, if symptoms last more than 7 days or clear up and reoccur

If pregnant or breastfeeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and older:

  • rub a thin film over affected area not more than 4 times daily, massage is not necessary

children under 2 years of age: consult a physician

Other Info

OTHER SAFETY INFORMATION

■ store in a cool dry place
■ do not use if tube seal under cap is broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzyl alcohol, butylated hydroxytoluene, camphor, carbopol 940, edetate disodium, DMDM hydantoin, FD&C blue no. 1, FD&C yellow no. 5,isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • arthritis
  • backache
  • strains
  • sprains

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN4
415974menthol 0.04 MG/MG Topical GelSCD4
415974menthol 4 % Topical GelSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-007-04Quality Choice Cold Therapy Gel118.2 mL in 1 BOTTLEGEL118.24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-007-04ML - Milliliter83324-0070eea5273-a298-4f02-859c-b58e996c9c5612026-04-20

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-00783324-007-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Quality Choice Cold Therapy GelMENTHOLChain Drug Marketing Association, Inc.f9c659cd-e7fa-ac2d-e053-6294a90a25732025-12-29WarningsExact identifier
ndc (package): 83324-007-04
ndc (product): 83324-007
ndc11 (package): 83324000704
spl id: 4721fb64-bc29-b450-e063-6294a90a056e
spl set id: f9c659cd-e7fa-ac2d-e053-6294a90a2573

Reported adverse events (FAERS/openFDA)#

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