Your browser does not support JavaScript! BITE AND ITCH (DIPHENHYDRAMINE HCL AND PRAMOXINE HCL) LOTION [WEEKS & LEO CO., INC.]
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BITE AND ITCH (diphenhydramine hcl and pramoxine hcl) lotion
[Weeks & Leo Co., Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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


Bite and Itch 4 oz Lotion

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

BITE AND ITCH 
diphenhydramine hcl and pramoxine hcl lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11383-193
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
MENTHOL 
MINERAL OIL 
POLYSORBATE 60 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
STEARYL ALCOHOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11383-193-04113 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/06/2000
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

Revised: 1/2011
 
Weeks & Leo Co., Inc.

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