BITE AND ITCH- diphenhydramine hydrochloride, pramoxine hydrochloride lotion

Bite and Itch by

Drug Labeling and Warnings

Bite and Itch by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Diphenhydramine HCl 2%

Pramoxine HCl 1%

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

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.

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

PRINCIPAL DISPLAY PANEL

Bite and Itch

Lotion

Pramoxine HCl 1%

Topical Anesthetic

Diphenhydramine HCl 2%

Antihistamine

Pain Relieving Lotion

4 Fl Oz (118 mL)

INGREDIENTS AND APPEARANCE

BITE AND ITCH 
diphenhydramine hydrochloride, pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-192
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
PEG-40 GLYCERYL STEARATE (UNII: 0A0VSM3HAD)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-192-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/15/2015
2	NDC: 11383-192-01	1 in 1 CARTON	06/15/2015
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/15/2015

Labeler - Weeks & Leo Co., Inc. (005290028)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-192)