Winco Original Strength Anti-itch Cream
FDA Label NDC 67091-277

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Original Strength Anti-itch (NDC 67091-277). 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, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, 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 (in each gram)                                                                            Purpose

Diphenhydramine hydrochloride 1%..................................................................... Topical analgesic

Zinc acetate 0.1%.............................................................................................. Skin protectant

Otc - Purpose

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, poison sumac
  • dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use

  • on chicken pox
  • on measles

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

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

Storage And Handling

Other information

  • store between 20° to 25°C (68 to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

cetanol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

Dosage & Administration

DISTRIBUTED BY:

WINCO FOODS, LLC

BOISE, ID 83704

MADE IN KOREA

* Please review the disclaimer below.