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  5. Label Information: Anti Itch Topical Analgesic

FDA Label for Anti Itch Topical Analgesic

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 - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. INDICATIONS & USAGE
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. DOSAGE & ADMINISTRATION
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti Itch Topical Analgesic Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Associations Inc. 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 Purpose

Diphenhydramine HCI 2%........................................................Topical analgesic

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


Otc - Purpose



Uses

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


Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use

  • on chicken pox
  • on measles

Otc - When Using



When using this product avoid contact with the 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 at room temperature 20-25°C (68-77°F)
  • protect from excessive heat (40°C/104°F), humidity, and light

Inactive Ingredient



inactive ingredients

cetostearyl alcohol, glyceryl stearate/peg-100 stearate, methylparaben, propylene glycol, propylparaben, purified water


Dosage & Administration



DISTRIBUTED BY:

C.D.M.A. INC.

43157 W. 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Made in China


* Please review the disclaimer below.