PROBALANCE HAND SANITIZER ADVANCED- alcohol gel

PROBALANCE Hand Sanitizer Advanced by

Drug Labeling and Warnings

PROBALANCE Hand Sanitizer Advanced by is a Otc medication manufactured, distributed, or labeled by LTD ENTERPRISES DISTRIBUTION, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PROBALANCE Hand Sanitizer Advanced Gel

Drug Facts

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from source of heat, fire or flame.

For external use only. Not for Consumption.

When using this product

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or redness develops and lasts.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

• place enough product in your palm to thoroughly cover your hands and rub hands together until dry.
• children under 6 years should be supervised when using this product.

Inactive ingredients

Water, hydroxypropyl guar, citric acid

Active ingredient

Alcohol 70% v/v

Other information

Other information

• store at a temperature below 110 F (43 C).
• may discolor certain fabrics or surfaces.

Package Label - Principal Display Panel

78072-501-10 - 1 gallon

INGREDIENTS AND APPEARANCE

PROBALANCE HAND SANITIZER ADVANCED 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78072-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78072-501-10	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
2	NDC: 78072-501-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/20/2020

Labeler - LTD ENTERPRISES DISTRIBUTION, INC. (092505379)

Registrant - LTD ENTERPRISES DISTRIBUTION, INC. (092505379)