PROBALANCE HAND SANITIZER ADVANCED- alcohol gel 
LTD ENTERPRISES DISTRIBUTION, INC.

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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PROBALANCE Hand Sanitizer Advanced Gel

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 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

Inactive ingredients

Water, hydroxypropyl guar, citric acid

Active ingredient

Alcohol 70% v/v

Other information

Other information

Package Label - Principal Display Panel

Label

78072-501-10 - 1 gallon

One Gallon Label

PROBALANCE HAND SANITIZER ADVANCED 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78072-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78072-501-103785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
2NDC:78072-501-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/20/2020
Labeler - LTD ENTERPRISES DISTRIBUTION, INC. (092505379)
Registrant - LTD ENTERPRISES DISTRIBUTION, INC. (092505379)

Revised: 5/2020
Document Id: a61a88bb-7327-3bf7-e053-2995a90a5ef3
Set id: a61a88bb-7326-3bf7-e053-2995a90a5ef3
Version: 1
Effective Time: 20200520
 
LTD ENTERPRISES DISTRIBUTION, INC.