Quality Choice Extra Strength Anti-itch Cream

Quality Choice Extra Strength Anti-itch Cream
SPL v3
SPL
SPL Set ID acdd7406-9dc3-235f-e053-2a95a90a2df7
Route
TOPICAL
Published
Effective Date 2020-08-14
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 Methylparaben Propylene Glycol Stearic Acid Glyceryl Monostearate Propylparaben Aloe Vera Leaf Cetyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-14

Description

Diphenhydramine Hydrochloride 2%

Purpose

Topical Analgesic


Medication Information

Indications and Usage

For the temporary relief from pain and itching associated with

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

Topical Analgesic

Description

Diphenhydramine Hydrochloride 2%

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 on chicken pox or measles

When using this product avoid contact with eyes

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
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

Distributed by CDMA Inc.

43157 W 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company owner of the registered trademark Benadryl.

Active Ingredient

Diphenhydramine Hydrochloride 2%

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

Questions? Call 1-800-935-2362

Inactive Ingredients

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

Stop Use and Ask A Doctor
  • 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 a Poison Control Center immediately


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief from pain and itching associated with

  • insect bites
  • minor burns
  • minor skin irritation
  • rashes due to poison ivy, poison oak, and poison sumac
  • dries the 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 on chicken pox or measles

When using this product avoid contact with eyes

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
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

Distributed by CDMA Inc.

43157 W 9 Mile Road

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company owner of the registered trademark Benadryl.

Active Ingredient

Diphenhydramine Hydrochloride 2%

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

Questions? Call 1-800-935-2362

Inactive Ingredients

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • 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 a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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