Otc - Active Ingredient
Active ingredients
Diphenhydramine HCl 2%
Pramoxine HCl 1%
Bite And Itch Lotion
FDA Label NDC 11383-192
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Weeks & Leo Co., Inc. for the product Bite And Itch (NDC 11383-192). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, instructions for use, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Topical analgesic
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
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
- chicken pox
- measles
- condition gets worse
- symptoms last for more than 7 days or clear up and occur again within a few days
Ask a doctor before use if you have
When using this product do not get into eyes
Stop use and ask a doctor if
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
Pramoxine HCl 1%
Topical Anesthetic
Diphenhydramine HCl 2%
Antihistamine
Pain Relieving Lotion
4 Fl Oz (118 mL)
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