Itch Relief Cream

Itch Relief Cream
SPL v8
SPL
SPL Set ID 37fe6d82-adee-4f58-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g) Zinc Cation (0.1 g)
Inactive Ingredients
Methylparaben Glyceryl Monostearate Petrolatum Laureth-23 Water Mineral Oil Propylparaben Stearyl Alcohol Propylene Glycol Stearic Acid Cetostearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-19

Description

Diphenhydramine Hydrochloride 2%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Diphenhydramine Hydrochloride 2%

Uses

For the temporary relief from pain and itcing assciated with:

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritation
  • minor cuts
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries weeping and oozing of poison ivy, oak, and sumac
Warnings

For External Use only

Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use if you have chicken pox or measles

When using this product avoid contact with eyes.

Packaging

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: consult a doctor
Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Active Ingredient

Diphenhydramine Hydrochloride 2%

Itch Relief Cream

Temporarily relieves the itching and pain associated with:

  • insect bites
  • allergic itch
  • skin irritations
Other Information
  • Store at controlled room temperature 20°-25°C (68°-77°F)
  • Close cap tightly after use
Inactive Ingredients

Aloe Vera (Aloe Barbadensis), leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Pil, Petrolatum, Polyoxyethylene, lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

Stop Use and Ask A Doctor If
  • Conditions worsen or do 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 the Reach of Children.

If swallowed, get medical help or contact Poison Control Center immediately


Structured Label Content

Uses

For the temporary relief from pain and itcing assciated with:

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritation
  • minor cuts
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries weeping and oozing of poison ivy, oak, and sumac
Purpose

Topical Analgesic

Warnings

For External Use only

Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use if you have chicken pox or measles

When using this product avoid contact with eyes.

Packaging

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: consult a doctor
Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Active Ingredient

Diphenhydramine Hydrochloride 2%

Itch Relief Cream

Temporarily relieves the itching and pain associated with:

  • insect bites
  • allergic itch
  • skin irritations
Other Information
  • Store at controlled room temperature 20°-25°C (68°-77°F)
  • Close cap tightly after use
Inactive Ingredients

Aloe Vera (Aloe Barbadensis), leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Pil, Petrolatum, Polyoxyethylene, lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)
  • Conditions worsen or do 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 the Reach of Children. (Keep out of the reach of children.)

If swallowed, get medical help or contact Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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