Diphenhydramine Hydrochloride, Pramoxine Hydrochloride

FDA Drug Profile — Bite and Itch

Drug Details

Generic Name
Diphenhydramine Hydrochloride, Pramoxine Hydrochloride
Brand Names
Bite and Itch
Application Number
M017
Sponsor
Weeks & Leo Co., Inc.
NDC Codes
1
Dosage Forms
LOTION
Routes
CUTANEOUS
Active Ingredients
DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE

Indications and 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

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 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. Do not use on large areas of the body with any other product containing diphynhydramine, 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 conditions get 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.