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  5. Label Information: Anti Itch

FDA Label for Anti Itch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Anti Itch Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. 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.

Active Ingredient



Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%


Purpose



Topical analgesic

Skin protectant


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 and poison sumac
  • •dries the oozing and weeping of poison ivy, poison oak and 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 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • •do not use more than directed
  • •adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • •children under 2 years of age: ask a doctor

Other Information



  • •store at 20°-25°C (68°-77°F)

Inactive Ingredients



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


Questions Or Comments?



1-800-632-6900


Principal Display Panel



COMPARE TO the active ingredients in EXTRA STRENGTH BENADRYL® ITCH STOPPING CREAM See Bottom Panel

Anti-itch Cream

(Diphenhydramine HCl, USP 2% / Zinc Acetate, USP 0.1%)

Topical Analgesic / Skin Protectant

EXTRA STRENGTH

For Temporary Relief of Itch and Pain Due to:

Insect Bites

Minor Skin Irritations

Rashes from Poison Ivy, Poison Oak or Poison Sumac

Anti-itch Cream

(Diphenhydramine HCl, USP 2% / Zinc Acetate, USP 0.1%)

Topical Analgesic / Skin Protectant

EXTRA STRENGTH

Itch and Rash Relief

NET WT 1 OZ (28 g)


* Please review the disclaimer below.