FDA Label for Leader Anti-itch
View Indications, Usage & Precautions
Leader Anti-itch Product Label
The following document was submitted to the FDA by the labeler of this product Leader/cardinal Health 110, Inc.. 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.
Active Ingredients
Camphor 0.5%............................................................................................................................ External analgesic
Menthol 0.5%.............................................................................................................................. External analgesic
Uses
temporary relieves pain and itching due to:
insect bites
minor burns
sunburn
minor skin irritations
minor cuts
scrapes
rashes due to poison ivy, poison oak, and poison sumac
Warning
For external use only
Ask Doctor Before Use
on chicken pox
on measles
When Using This Product
do not get into eyes
Stop Use And Ask 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.
Purpose
Anti - itch
Directions
to open, squeeze cap tightly and turn pump counter-clockwise
adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor
Other Information
store at 20 °C to 25 °C (68 °F to 77 °F)
Inactive Ingredients
carbomer 940, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl
stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate,
purified water, sodium hydroxide, stearic acid, white petrolatum
Principal Display Panel
Compare to Sarna Original Anti-Itch lotion
Original Formula Anti-Itch Lotion
Camphor 0.5%
Menthol 0.5%
Steroid Free
Relief from itching associated with dry skin, insectr bites, poison ivy and Sunburn
Cools and Soothes
* Please review the disclaimer below.