ANTI-ITCH CREAM- diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Trifecta Pharmaceuticals USA, LLC.

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Skin Protectant 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 - 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

Authorization status:

OTC monograph final

Summary of Product characteristics

ANTI-ITCH CREAM- DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE
0.1% CREAM
TRIFECTA PHARMACEUTICALS USA, LLC.
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ANTI-ITCH CREAM
_ACTIVE INGREDIENT_
Diphenhydramine Hydrochloride 2%
_PURPOSE_
Topical Analgesic
_ACTIVE INGREDIENT_
Zinc Acetate 0.1%
_PURPOSE_
Skin Protectant
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
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
_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
_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
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
_DISTRIBUTED BY:_
TRIFECTA PHARMACEUTICALS USA, LLC.
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL. 33301 USA
Product of PRC
WWW.TRIFECTA-PHARMA.COM
PACKAGING
ANTI-ITCH CREAM
diphenhydramine hydrochloride 2%, zinc acetate 0.1% cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM C