FDA Label for Leader Anti Itch Maximum Strength
View Indications, Usage & Precautions
Leader Anti Itch Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients Purpose
Diphenhydramine Hydrochloride 2%....................................................Topical analgesic
Zinc acetate 0.1%.............................................................................Skin protectant
Otc - Purpose
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
Warnings
For external use only.
Otc - Do Not Use
Do not use
- on large areas of the body
- with any other product containing diphenhydramine, even one taken by mouth
Otc - Ask Doctor
Ask a doctor before use
- on chicken pox
- on measles
Otc - When Using
When using this product
- avoid contact with eyes
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center
Indications & Usage
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
Storage And Handling
Other information
- Store between 20
oC and 25
oC (68
oF and 77
oF)
Inactive Ingredient
Inactive ingredients
cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, and purified water
Dosage & Administration
DISTRIBUTED BY CARDINAL HEALTH
DULIN, OHIO 43017
CIN 2372134
www.myleader.com
1-800-200-6313
Package Label.Principal Display Panel
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