Anti-Itch Cream

Manufacturer
Front Pharmaceutical PLC | Front Pharmaceutical
Effective date
2023-09-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:25:30

Label at a glance#

ProductAnti-Itch Cream
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Label structure14 sections

Dosage and administration

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times per day. children under 2 years of age: ask a doctor before use

Storage and handling

store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C). tamper-evident: do not use if foil seal is broken or missing.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Zinc Acetate 0.1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Skin Protectant

Use

INDICATIONS & USAGE SECTION

for temporary relief from pain and itching associated with insect bites, sunburn, and minor skin irritations. Dries the oozing and weeping of poison:

  • ivy
  • oak
  • sumac

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • over large areas of the body
  • with any other product containing diphenhydramine, including those taken orally

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last for more than 7 days
  • the condition gets worse
  • symptoms clear up and then occur again within a few days

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times per day.
  • children under 2 years of age: ask a doctor before use

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polyoxyethylene lauryl ether, propylene glycol, propylparaben, purified water, stearic acid, stearyl alcohol

Questions

OTC - QUESTIONS SECTION

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 59 degrees - 77 degrees F (15 degrees - 25 degrees C).
  • tamper-evident: do not use if foil seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

Anti-Itch Cream

Topical Analgesic and Skin Protectant Cream

Net Wt 1 oz (28 g)

Front PanelFront Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69571-011-012025-01-30C16284748780-12cef2736-59e6-d83d-e063-dadaa90ab31fFourstar Group Anti-Itch Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69571-011ANTI-ITCH CREAM (DIPHENHYDRAMINE HCL / ZINC ACETATE) CREAM [FRONT PHARMACEUTICAL PLC]1Unmatched20230928_05d3f15b-bb34-191a-e063-6294a90a3b4a.zip

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
69571-01169571-011-01

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
05d3f15b-bb35-191a-e063-6294a90a3b4a05d3f15b-bb34-191a-e063-6294a90a3b4a2023-09-20WarningsExact identifier
spl id: 05d3f15b-bb35-191a-e063-6294a90a3b4a
spl set id: 05d3f15b-bb34-191a-e063-6294a90a3b4a

Reported adverse events (FAERS/openFDA)#

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