best choice itch stopping cream

best choice itch stopping cream
SPL v1
SPL
SPL Set ID 11368823-d4af-a536-e063-6294a90a7a2e
Route
topical
Published
Effective Date 2023-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (2 g) zinc cation (0.1 g)
Inactive Ingredients
laureth-23 water petrolatum mineral oil cetyl alcohol methylparaben propylene glycol stearic acid glyceryl monostearate propylparaben aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-29

Purpose

Topical Analgesic

Description

Diphenhydramine Hydrochloride 2%


Medication Information

Warnings

For External Use Only

Indications and Usage

Temporarily relieves pain and itching associated with

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

Topical Analgesic

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
Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)
  • Close cap tightly after use

Inactive Ingredients

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

Description

Diphenhydramine Hydrochloride 2%

Packaging

Do Not Use

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

Distributed By:

Proudly Distributed by Associated Wholesale Grocers Inc.

Kansas City, KS. 66106 USA

Questions Call: 1-877-753-3935

Monday-Friday 9AM-5PM EST

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Extra Strength Benadryl® Itch Stopping Cream.

00000 Rev0000000000

Active Ingredient

Diphenhydramine Hydrochloride 2%

Ask A Doctor Before Use

Ask a doctor before use on chicken pox or measles

When Using This Product

When Using this Product avoid contact with Eyes

Stop Use and Ask A Doctor If

Stop Use and Ask a Doctor if

  • Conditions worsen or do not improve within 7 days
  • Symptoms presist 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 a Poison Control Center immediately


Structured Label Content

Warnings

For External Use Only

Indications and Usage (34067-9)

Temporarily relieves pain and itching associated with

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

Topical Analgesic

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
Other Information (Other information)
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)
  • Close cap tightly after use

Inactive Ingredients

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

Packaging

Do Not Use

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

Distributed By:

Proudly Distributed by Associated Wholesale Grocers Inc.

Kansas City, KS. 66106 USA

Questions Call: 1-877-753-3935

Monday-Friday 9AM-5PM EST

This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., owner of the registered trademark Extra Strength Benadryl® Itch Stopping Cream.

00000 Rev0000000000

Active Ingredient

Diphenhydramine Hydrochloride 2%

Ask A Doctor Before Use (Ask a Doctor before Use)

Ask a doctor before use on chicken pox or measles

When Using This Product (When Using this product)

When Using this Product avoid contact with Eyes

Stop Use and Ask A Doctor If (Stop Use and Ask a Doctor If)

Stop Use and Ask a Doctor if

  • Conditions worsen or do not improve within 7 days
  • Symptoms presist 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 a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)