Palmer's with Vitamin E Advanced Hand Sanitizer Soothing Aloe Gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hayward Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Hayward Laboratories 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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Palmer's with Vitamin E Advanced Hand Sanitizer Soothing Aloe Gel

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product

When using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water.

Stop use and ask doctor

Stop use and ask a doctor if irritation or rash appears ans last.

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

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 43C (110F)
• May discolor certain fabrics or surfaces

Inactive ingredients

water(aqua), glycerin, isopropyl alcohol, aloe barbadensis leaf juice, tocopheryl acetate, citric acid, potassium sorbate, ammonium acryloyldimethyltaurate/vp copolymer, sodium benzoate, fragrance (parfum),yellow 5 (CI 19140), blue 1 (CI 42090)

Package Label - Principal Display Panel

Palmer's with Vitamin E Advanced Hand Sanitizer Soothing Aloe Gel

kills more than 99.99% of germs

150ml/5.1 fl.oz e

E.T. Browne Drug Co. Inc.

Englewood Cliffs, NJ 07632 USA

©2020 E.T. Browne Drug Co. INc.

Made in hte USA with domestic and imported components

Family owned & operated logo

Flammable logo

www.palmers.com

150mL NDC: 12094-4910-2

UPC 0 10181 04912 5

Package Label Principal Display Panel

Palmer's with Vitamin E Advanced Hand Sanitizer Sothing Aloe Gel

Kills More than 99.99% of Germs

100ml/3.4fl.oz e

E.T. Browne Drug Co. Inc.

Engkewood Cliffs, NJ 07632 USA

© 2020 E.T. Browne Drug Co. Inc.

Made in USA with domestic and imported components

Family Owned & Operated Label

Flammable Label

www.palmers.com

NDC: 12094-4916-0

UPC 0 10181 04916 3

Package Label Principal Display Panel

Palmer's with Vitamin E Advanced Hand Sanitizer Soothing Aloe Gel

340ml/11.5 fl.oz e

UPC 0 10181 04917 0

NDC: 12094-4917-0

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12094-4916
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.00003 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.00012 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0001 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.5 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	26.09977 mL  in 100 mL
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)	0.8 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.09973 mL  in 100 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.0001 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.0001 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.00005 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12094-4916-0	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2021	10/01/2021

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12094-4917
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
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)	0.8 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.00012 mL  in 100 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.0001 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.0001 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	26.09977 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.5 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.09973 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0001 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.00003 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.00005 mL  in 100 mL

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12094-4917-0	340 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2021	10/01/2021

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12094-4910
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
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)	0.8 mL  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	0.00012 mL  in 100 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.0001 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.0001 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	26.09977 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.5 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.09973 mL  in 100 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.0001 mL  in 100 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.00003 mL  in 100 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.00005 mL  in 100 mL

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12094-4910-2	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2021	10/01/2021

Labeler - Hayward Laboratories Inc. (800195513)

Establishment
Name	Address	ID/FEI	Business Operations
Hayward Laboratories Inc.		800195513	manufacture(12094-4910, 12094-4916, 12094-4917)

Revised: 2/2022

Document Id: d76df547-9ddb-2db4-e053-2995a90a4299

34390-5

Set id: af82f750-c7b8-b5c2-e053-2a95a90a3842

Version: 6

Effective Time: 20220207