THE ITCH ERASER SENSITIVE- sodium bicarbonate cream

The Itch Eraser Sensitive by

Drug Labeling and Warnings

The Itch Eraser Sensitive by is a Otc medication manufactured, distributed, or labeled by Adventure Ready Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

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.

SPL UNCLASSIFIED SECTION

​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:

INGREDIENTS AND APPEARANCE

THE ITCH ERASER SENSITIVE 
sodium bicarbonate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90107-2420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90107-2420-1	4 in 1 BOX	09/01/2020
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2020

Labeler - Adventure Ready Brands (064437304)

Registrant - Adventure Ready Brands (064437304)

Establishment
Name	Address	ID/FEI	Business Operations
Adventure Ready Brands		064437304	manufacture(90107-2420)