THE ITCH ERASER MAX STRENGTH- diphenhydramine hydrochloride gel 
Tender Corporation

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.

----------

The Itch Eraser Max Strength Gel

Drug Facts

Active ingredients:

Diphenhydramine HCl 2%

Purpose:

Topical analgesic

​Uses

​For temporary relief of pain and itching associated with:

  • insect bites
  • minor burns
  • sunburn
  • minor skin irritations
  • minor cuts
  • rashes due to poison: ivy, oak and sumac

​Warnings

​For external use only

  • ​do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last 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 diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

​Directions

  • do not use more often than directed
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • ​children under 2 years of age: ​ask a doctor

​Inactive Ingredients

Purified Water, Aloe Vera, Sodium Bicarbonate (Baking Soda), Ammonia, Carbopol, Oat Beta Glucan, Glycerin, Vitamin E Acetate and Tea Tree Oil

Package Labeling:

TubeCarton1

THE ITCH ERASER MAX STRENGTH 
diphenhydramine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-2400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
AMMONIA (UNII: 5138Q19F1X)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44224-2400-04 in 1 BOX11/17/201503/01/2018
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/17/201503/01/2018
Labeler - Tender Corporation (064437304)
Establishment
NameAddressID/FEIBusiness Operations
Tender Corporation064437304manufacture(44224-2400)

Revised: 3/2018
 
Tender Corporation