The Itch Eraser Sensitive Cream

The Itch Eraser Sensitive Cream

Drug Labeling and Warnings

Drug Details

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THE ITCH ERASER SENSITIVE- sodium bicarbonate cream 
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.

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The Itch Eraser Sensitive Cream

Drug Facts

Active ingredients 

Sodium Bicarbonate (BakingSoda) 5%

Purpose

Skin Protectant

​Uses

​Temporarily protects and helps relieve minor skin irritation and itching due to:

  • ​insect bites
  • poison: ivy, oak, and sumac

​Warnings

​For external use only

When using this product

  • 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.

​If in eyes ​flush with water for 15 minutes and call a doctor

​Directions

  • ​Adults and children 2 years and older​ dab directly on bite or sting, rub gently and re-apply as needed
  • ​children under 2 years of age:​ ask a doctor.

​Inactive Ingredients

Aloe Vera, Dimethicone, Emulsifying Wax, Eucalyptus Oil, Oleth-3 Phosphate, Oleth-10, Phosphate, Purified Water, Sodium Hydroxide, Vitamin E Acetate, and Tea Tree Oil

Package Labeling:

Tube1Carton

THE ITCH ERASER SENSITIVE 
sodium bicarbonate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 44224-2420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
OLETH-10 (UNII: JD797EF70J)  
PHOSPHATE ION (UNII: NK08V8K8HR)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 44224-2420-04 in 1 BOX
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/17/2015
Labeler - Tender Corporation (064437304)
Establishment
NameAddressID/FEIBusiness Operations
Tender Corporation064437304manufacture(44224-2420)

Revised: 11/2015
 
Tender Corporation


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