SPL v1
SPL
SPL Set ID 82e6a91c-fb8b-42b5-8b01-3db180b9d7fc
Route
TOPICAL
Published
Effective Date 2012-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g) Zinc (0.1 g)
Inactive Ingredients
Cetyl Alcohol Diazolidinyl Urea Methylparaben Peg-2 Stearate Peg-20 Stearate Propylene Glycol Propylparaben Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2008-04-23

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

Purpose

Topical analgesic Skin protectant


Medication Information

Purpose

Topical analgesic

Skin protectant

Description

Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

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

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
Do Not Use
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Active Ingredient

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

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?

1-800-616-2471

Ask A Doctor Before Use
  • on chicken pox
  • on measles
Principal Display Panel

Diphenhydramine Hydrochloride 2%

Cream

28 g

NDC 54868-0113-0





Extra Strength

Anti-Itch Cream

Topical Analgesic/Skin Protectant









Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

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.


Structured Label Content

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
Purpose

Topical analgesic

Skin protectant

Warnings

For external use only

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
Do Not Use (Do not use)
  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth
Active Ingredient (Active ingredient)

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Other Information (Other information)
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-616-2471

Ask A Doctor Before Use (Ask a doctor before use)
  • on chicken pox
  • on measles
Principal Display Panel

Diphenhydramine Hydrochloride 2%

Cream

28 g

NDC 54868-0113-0





Extra Strength

Anti-Itch Cream

Topical Analgesic/Skin Protectant









Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma       74146

When Using This Product (When using this product)
  • avoid contact with the eyes
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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