Signature Care Itch Relief Cream
FDA Label NDC 21130-154

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Signature Care Itch Relief (NDC 21130-154). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, ask a doctor before use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Uses

  • temporarily relieves pain and itching associated with:
  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • scrapes
  • rashes due to poison ivy, poison oak and poison sumac
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only

Do Not Use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask A Doctor Before Use

  • on chicken pox
  • on measles

When Using This Product

  • avoid contact with the eyes

Stop Use And Ask A Doctor If

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Questions Or Comments?

1-888-723-3929

Principal Display Panel

COMPARE TO Extra Strength Benadryl® Itch Stopping Cream active ingredients

Itch Relief Cream

DIPHENHYDRAMINE HCl 2%, ZINC ACETATE 0.1%

Topical Analgesic – Skin Protectant

EXTRA STRENGTH

Relieves Itches from Insect Bites & Skin Irritations

NET WT 1 OZ (28 g)

Signature Care Itch Relief Cream Image 1 (Image 01)

Signature Care Itch Relief Cream Image 1 (Image 01)

Signature Care Itch Relief Cream Image 2 (Image 02)

Signature Care Itch Relief Cream Image 2 (Image 02)

* Please review the disclaimer below.