Anti-itch
FDA Label NDC 52000-023

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Anti-itch (NDC 52000-023). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Diphenhydramine Hydrochloride  2%

Zinc Acetate  0.1%

Otc - Purpose

Purpose

Topical Analgesic

Skin Protectant

Indications & Usage

Uses

For the temporary relief of pain and itching associated with:

  • minor skin irritation
  • allergic itches
  • rashes
  • hives
  • minor burns
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac

Warnings

Warnings

Otc - Do Not Use

Do not use on children under 2 years of age.

For external use only

  • avoid contact with eyes
  • do not apply to open wound or damaged skin.

Otc - Stop Use

Stop use and ask a doctor

  • if condition worsens
  • symptoms persist for 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

  • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

  • For children under 2 years of age: consult a physician.

Other

Other information

  • Store at 20°C to 25°C (68°F to 77°F).

Inactive Ingredient

Inactive ingredients

Cetyl Alcohol, Diazolidinly urea, Methylparaben, Polyethylene Glycol Monostearate 1000, Propylene Gylcol, Propylparaben, Aloevera extract, Alpha-Tocopherol Acetate, Purified Water.

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

Anti-Itch Cream

NET WT 1 OZ (28 g)

Image Of Package Label (Anti Itch)

Image Of Package Label (Anti Itch)

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