DG Health Cold Zone Pain Relieving Gel Topical Analgesic

Manufacturer
Dolgencorp Inc | Garcoa, Inc. | SV Labs Toronto Corporation
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:17:02

Label at a glance#

ProductDG Health Cold Zone Pain Relieving Topical Analgesic
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Dosage and administration

adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pads or other heating devices

OTC - STOP USE SECTION

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

SPL UNCLASSIFIED SECTION

Flammable

  • keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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 (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrtata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DG™|health

Compare to
active
ingredient
of BIOFREEZE®
GEL*

Cold Zone
Pain Relieving
Gel

Topical Relief
Menthol 4% Topical Analgesic

  • For arthritis, backache,
    muscle pain and joint pain
  • Soothing Menthol
  • Paraben free

2 FL OZ (59 mL)

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label
PRINCIPAL DISPLAY PANEL - 59 mL Tube Label

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-884-01DG Health Cold Zone Pain RelievingTopical Analgesic59 mL in 1 TUBEGEL594

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-88455910-884-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
DG Health Cold Zone Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMDolgencorp Inc22594ab8-9a4a-426f-aced-5c636620fa2c2024-11-08WarningsExact identifier
ndc (package): 55910-884-01
ndc (product): 55910-884
ndc11 (package): 55910088401
spl id: fc5f360e-a820-4ba3-8c6a-8271aa68010e
spl set id: 22594ab8-9a4a-426f-aced-5c636620fa2c

Reported adverse events (FAERS/openFDA)#

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