Anti-itch
FDA Label NDC 29500-2437

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products, Inc. for the product Anti-itch (NDC 29500-2437). 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, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Drug Facts

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

For the temporary relief from pain and itching associated with:

  • insect bites
  • sunburn
  • minor skin irritations
  • minor burns
  • scrapes


    • Dries the oozing and weeping of

    • poison ivy
    • poison oak
    • 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 day or clear up and occur again within a few days

Directions

  • do not use more than directed
  • 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
  • use daily for 4 weeks

Other Information

  • store at temperature between 58° - 77° F  (15° - 30° C)
  • do not use if seal on tube is punctured or missing

Inactive Ingredients

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

Product Label

DRUGSTORE-Rx

SMART WELLNESS

Extra Strength

Anti-Itch Cream

Topical Analgesic and Skin Protectant

Histamine Blocker

Relieves itching from

    * Poison ivy
    * Poison sumac
    * Sunburn
    * Insect bites


NET WT. 1.25 OZ.  (35 g)

DRUGSTORE-Rx

SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item. That's smart wellness!

Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 48084 U.S.A.

Code No. MH/DRUGS/KD-313               Made in India


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