CVS ITCH RELIEF- pramoxine hydrochloride and zinc acetate lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056), ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)

Available from:

CVS Pharmacy

INN (International Name):

PRAMOXINE HYDROCHLORIDE

Composition:

PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

External Analgesic Skin Protectant Dries the oozing and weeping, and temporarily relieves pain and itching of poison ivy, oak, and poison sumac and other minor skin irritations.

Authorization status:

OTC monograph final

Summary of Product characteristics

CVS ITCH RELIEF- PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION
CVS PHARMACY
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CVS ITCH RELIEF
CVS ITCH RELIEF
Drug Facts
ACTIVE INGREDIENT
Pramoxine HCl 1%
Zinc Acetate 0.1%
PURPOSE
External Analgesic
Skin Protectant
USE
Dries the oozing and weeping, and temporarily relieves pain and
itching of poison ivy,
oak, and poison sumac and other minor skin irritations.
WARNINGS
FOR EXTERNAL USE ONLY. Use only as directed. Avoid contact with eyes
and mucous
membranes, Ask doctor before using in children under 2 years of age.
STOP USE AND ASK A DOCTOR IF
condition worsens. Symptoms last for more than 7 days or clear up and
occur again
within a few days.
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion, seek professional assistance or
contact a Poison Control
Center immediately.
DIRECTIONS
ADULTS AND CHILDREN 2 YRS. OF AGE AND OLDER. Shake well before using.
Cleanse
the skin with soap and water and let dry. Apply to the affected area
using cotton or
soft cloth not more than 3 to 4 times daily as needed for comfort.
CHILDREN UNDER 2 YRS. OF AGE: Consult a doctor before use.
INACTIVE INGREDIENT
SD Alcohol 38B 2.5%, Camphor, Diazolidinyl Urea, Fragrances, Glycerin,
Hydroxypropyl Methylcellulose, Methylparaben, Polysorbate 80,
Propylene Glycol,
Propylparaben, and Purified Water.
OTHER INFORMATION
store at room temperature 15
– 30
C (59
– 85
F)
PRINCIPAL DISPLAY PANEL
CVS Health
Itch Relief
CLEAR SKIN PROTECTANT
6 FL OZ (177 mL)
o
o
o
o
CVS ITCH RELIEF
pramoxine hydrochloride and zinc acetate lotion
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:69842-400
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE -
UNII:068X84E056)
PRAMOXINE
HYDROCHLORIDE
10 mg
in 1 mL
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)
ZINC ACETATE
1 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
DIAZOLIDINY