IVAREST- zinc oxide, benzyl alcohol, and diphenhydramine hydrochloride cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z), Benzyl Alcohol (UNII: LKG8494WBH) (Benzyl Alcohol - UNII:LKG8494WBH), Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)

Available from:

Blistex Inc

INN (International Name):

Zinc Oxide

Composition:

Zinc Oxide 14 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations. - dries the oozing and weeping of poison: ivy oak sumac - ivy - oak - sumac

Authorization status:

OTC monograph final

Summary of Product characteristics

IVAREST- ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE
CREAM
BLISTEX INC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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IVARES T
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Calamine 14.0 % (w/w)
Skin protectant
Benzyl Alcohol 10.5 % (w/w)
External
analgesic
Diphenhydramine Hydrochloride 2.0 % (w/w)
External
analgesic
US ES
for the temporary relief of pain and itching associated with poison
ivy, poison oak, poison sumac,
insect bites or minor skin irritations.
dries the oozing and weeping of poison:
ivy
oak
sumac
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
on large areas of the body
with any other product containing diphenhydramine, even one taken by
mouth
ASK A DOCTOR BEFORE USE
on chicken pox
on measles
WHEN USING THIS PRODUCT
do not get into eyes.
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last more than 7 days or clear up and occur again within a
few days
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
do not use more often than directed
as soon as possible after exposure, wash affected area with soap and
water (or Ivarest Poison Ivy
Cleansing Foam). Gently pat dry.
®
apply Ivarest liberally to form a layer you can not see through.
adults and children 2 years 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
_Avoid contact with clothing. Ivarest may stain certain fabrics._
INACTIVE INGREDIENTS
bentonite, benzethonium chloride, camphor, hydroxyethyl
acrylate/sodium acryloyldimethyl taurate
copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil,
magnesium aluminum silicate, menthol,
petrolatum, PEG-4, polyglyceryl-3 diisostearate, polysorbate 60,
propylene glycol, purified water,
PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6
PRINCIPAL DISP