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Itch Relief by Safetec of America, Inc.

Dosage form: liquid
Ingredients: diphenhydramine hydrochloride 20.3g in 1L
Labeler: Safetec of America, Inc.
NDC Code: 61010-8300

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.

Drug Facts

Active Ingredients

Diphenhydramine hydrochloride 2%

Purpose

External Analgesic

Uses:

For the temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and poison sumac.

Warnings

For external use only

Do not use
  • on large areas of the body
  • with any other products using diphenhydramine hydrochloride, even one taken by mouth

Ask a doctor before use
  • on chicken pox
  • on measles

When using this product
  • avoid contact with the eyes

Stop use and ask doctor if
  • condition worsens
  • symptoms persist 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 center right away.

Directions:
  • 12 and over: apply to affected area not more than 3 to 4 times daily
  • under 12: consult a doctor

Inactive Ingredients:

Germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

PRINCIPAL DISPLAY PANEL

NDC 61010-8300-1

Safetec

Diphenhydramine

Itch Relief Spray

Relief from pain and

itching due to insect

bites and rashes from

poison ivy, poison oak

and poison sumac.

Manufactured by

SAFETEC OF AMERICA, Inc.

Buffalo, NY 14215 800-456-7077

www.safetec.com

2 fl. oz. (59.1ml) Reorder no. 57001

ITCH RELIEF 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8300
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine hydrochloride (diphenhydramine) diphenhydramine hydrochloride20.3 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
diazolidinyl urea 
edetate disodium 
glycerin 
C12-15 PARETH-9 
water 
trolamine 
Packaging
#Item CodePackage Description
1NDC:61010-8300-10.0591 L in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/02/2013
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(61010-8300)

Revised: 05/2013
 
Safetec of America, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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