LEADER ANTI ITCH MAXIMUM STRENGTH- diphenhydramine hydrochloride, zinc acetate 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:

CARDINAL HEALTH

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses temporarily relieves pain and itching associated with - insect bites - minor burns - sunburn - minor skin irritations - minor cuts - scrapes - rashes due to poison ivy, poison oak, and poison sumac Dries the oozing and weeping of poison ivy, poison oak and poison sumac Do not use - on large areas of the body - with any other product containing diphenhydramine, even one taken by mouth Stop use and ask a doctor if - condition worsens or does 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 no more than 3 to 4 times daily - children under 2 years of age: ask a doctor

Authorization status:

OTC monograph not final

Summary of Product characteristics

LEADER ANTI ITCH MAXIMUM STRENGTH- DIPHENHYDRAMINE HYDROCHLORIDE, ZINC
ACETATE CREAM
CARDINAL HEALTH
_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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LEADER ANTI-ITCH CREAM 1 OZ. NBE BENADRYL MAXIMUM STRENGTH
Active ingredients Purpose
Diphenhydramine Hydrochloride
2%....................................................Topical
analgesic
Zinc acetate
0.1%.............................................................................Skin
protectant
Uses
temporarily relieves pain and itching associated with
insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
Dries the oozing and weeping of poison ivy, poison oak and poison
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
avoid contact with eyes
Stop use and ask a doctor if
condition worsens or does 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 reach of children.
If swallowed, get medical help or contact a Poison Control Center
Directions
do not use more than directed
adults and children 2 years of age and older: apply to affected area
no more than 3 to 4 times daily
children under 2 years of age: ask a doctor
Other information
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Store between 20
C and 25
C (68
F and 77
F)
Inactive ingredients
cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol
monostearate 1000, propylene
glycol, propylparaben, and purified water
DISTRIBUTED BY CARDINAL HEALTH
DULIN, OHIO 43017
CIN 2372134
www.myleader.com
1-800-200-6313
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LEADER ANTI ITCH MAXIMUM STRENGTH
diphenhydramine hydrochloride, zinc acetate cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMA