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  5. Label Information: Winco Original Strength Anti-itch

FDA Label for Winco Original Strength Anti-itch

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - ASK DOCTOR
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. INDICATIONS & USAGE
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. DOSAGE & ADMINISTRATION
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Winco Original Strength Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.