FDA Label for Bite And Itch

View Indications, Usage & Precautions

OTC - ACTIVE INGREDIENT
OTC - PURPOSE
INDICATIONS & USAGE
INSTRUCTIONS FOR USE
WARNINGS
OTC - DO NOT USE
OTC - ASK DOCTOR
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
OTHER SAFETY INFORMATION
INACTIVE INGREDIENT
DOSAGE & ADMINISTRATION
RECENT MAJOR CHANGES
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bite And Itch Product Label

The following document was submitted to the FDA by the labeler of this product Weeks & Leo Co., 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.

Otc - Active Ingredient

Active ingredients

Diphenhydramine HCl 2%

Pramoxine HCl 1%

Otc - Purpose

Purposes

Topical analgesic

Indications & Usage

Uses

Temporarily relieves pain and itching due to:

scrapes
sunburn
minor cuts
minor burns
insect bites
minor skin irritations
poison ivy, poison oak, or poison sumac

Instructions For Use

Directions

do not use more often than directed
adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
children under 12 years: ask a doctor

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 if you have

chicken pox
measles

When using this product do not get into eyes

Stop use and ask a doctor if

condition gets worse
symptoms last 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 right away.

Otc - Do Not Use

Do not use

on large areas of the body
with any other product containing diphynhydramine, even one taken by mouth

Otc - Ask Doctor

Ask a doctor before use if you have

chicken pox
measles

Otc - When Using

When using this product do not get into eyes

Otc - Stop Use

Stop use and ask a doctor if

conditions get worse
symptoms last 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 right away.

Other Safety Information

Other information

store at controlled room temperature
call (515) 276-1586 to report any side effects that may occur

Inactive Ingredient

Inactive ingredients

cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

Dosage & Administration

Directions

do not use more often than directed
adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
children under 12 years: ask a doctor

Recent Major Changes

Added Dosage and Administration section

Updated Warnings section

Package Label.Principal Display Panel

Bite and Itch

Lotion