Anti-itch Cream

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (2 g) Zinc Cation (0.1 g)

Inactive Ingredients

Laureth-23 Water Cetostearyl Alcohol Petrolatum Mineral Oil Stearyl Alcohol Methylparaben Propylene Glycol Stearic Acid Glyceryl Monostearate Propylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-12-29

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:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

Active Ingredient

Diphenhydramine Hydrochloride 2%

Other Information

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

Questions? Call 1-888-296-9067

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:

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

Product of PRC

www.trifecta-pharma.com

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 1-888-296-9067

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

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Raw Label Data

All Sections (JSON)

{"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", "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:": "Trifecta Pharmaceuticals USA, LLC. 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 USA Product of PRC www.trifecta-pharma.com", "Active Ingredient": "Diphenhydramine Hydrochloride 2%", "Other information": "Store at controlled room temperature 20º-25ºC (68º-77ºF) Close cap tightly after use Questions? Call 1-888-296-9067", "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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information