BITE AND ITCH- diphenhydramine hcl and pramoxine hcl lotion 
Weeks & Leo Co., Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Diphenhydramine HCl 2 %

Pramoxine HCl 1 %

Purpose

Topical Analgesic

Topical Analgesic

Uses

temporarily relieves pain and itching due to:

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

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 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.

Directions

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

Other information

  • store at controlled room temperature

Inactive ingredients

cetyl alcohol, glyceryl monostearate, isopropyl myristate, menthol, mineral oil, polysorbate 60, propylene glycol, purified water, sodium benzoate, stearyl alcohol

Bite and Itch Lotion 4 oz Labeling

This product is also labeled as Solarhist Lotion. All other labeling and packaging is the same.

Labeled and Dist. by:

Weeks and Leo Co. Inc.

Des Moines, IA 50322

Bite and Itch Lotion 4oz

BiteAndItch.jpg

Bite & Itch

BITE AND ITCH 
diphenhydramine hcl and pramoxine hcl lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-193
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MENTHOL (UNII: L7T10EIP3A)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11383-193-04113 g in 1 BOTTLE; Type 0: Not a Combination Product01/06/200009/26/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/06/200009/26/2012
Labeler - Weeks & Leo Co., Inc. (005290028)
Registrant - DSC Laboratories, Div. of DSC Products Inc. (097807374)
Establishment
NameAddressID/FEIBusiness Operations
DSC Laboratories, Div. of DSC Products Inc.097807374manufacture(11383-193)

Revised: 10/2016
Document Id: 3e4671ad-1de7-705e-e054-00144ff8d46c
Set id: 70c5bb8c-24d2-448b-a3b1-92c7f4754614
Version: 4
Effective Time: 20161007
 
Weeks & Leo Co., Inc.