DG™ Health Medicated Anti-Itch Cream Topical Analgesic

Manufacturer
DOLGENCORP, LLC | Natureplex LLC
Effective date
2020-08-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:50

Label at a glance#

ProductDG Health Medicated Anti-Itch Analgesic
Active ingredientMenthol, Unspecified Form, Pramoxine Hydrochloride
Label structure10 sections

Dosage and administration

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

Storage and handling

store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Menthol 1%Anti-itch, pain relief
Pramoxine hydrochloride 1%Anti-itch, pain relief

Use

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor skin irritations, minor burns, minor cuts, sunburns, scrapes, insect bites, and rashes due to poison ivy, poison oak, or poison sumac

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes and nose.

Not for prolonged use.

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, irritation, swelling, or pain develops, persists, or increases

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 right away: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, cetearyl alcohol, DMDM hydantoin, glycerin, polysorbate 60, propylene glycol, purified water, triethanolamine

Questions or comments?

OTC - QUESTIONS SECTION

888-309-9030

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DG™| health

Compare to the active ingredients
of Gold Bond® Medicated
Anti-Itch Cream*

Medicated
Anti-Itch Cream
Menthol, Pramoxine Hydrochloride

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116155menthol 1 % / pramoxine HCl 1 % Topical CreamPSN2
1116155menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCD2
1116155menthol 1 % / pramoxine hydrochloride 1 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-330-242025-01-30C16284748780-12cef2736-6e67-d83d-e063-dadaa90ab31fDG™ Health Medicated Anti-Itch Cream Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-330-24DG Health Medicated Anti-Itch Analgesic28 g in 1 TUBECREAM282
55910-330-24DG Health Medicated Anti-Itch Analgesic1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-330DG HEALTH MEDICATED ANTI-ITCH ANALGESIC (MENTHOL, UNSPECIFIED FORM AND PRAMOXINE HYDROCHLORIDE) CREAM [DOLGENCORP, LLC]2Legacy NDC, 2 package rows20200826_bf0234f3-0dfb-4e0c-a321-9829137526c3.zip

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
55910-33055910-330-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

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
611ebafc-c024-4a34-8310-67055526fa41bf0234f3-0dfb-4e0c-a321-9829137526c32020-08-25WarningsExact identifier
spl id: 611ebafc-c024-4a34-8310-67055526fa41
spl set id: bf0234f3-0dfb-4e0c-a321-9829137526c3

Reported adverse events (FAERS/openFDA)#

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