Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

NDC 78084-001: purified water USP, glycerin, carbomer, triethanolamine.

NDC 78084-002: purified water USP, glycerin, carbomer, triethanolamine, aloe vera.

Package Label - Principal Display Panel

500 mL NDC:78084-001-01 500 mL

1000 mL NDC: 78084-001-02 1000mL

200000 mL NDC: 78084-001-03 200L

500 mL NDC:78084-002-01

500 aloe

1000 mL NDC:78084-002-02

1 L aloe

250 mL NDC:78084-002-03

250 Aloe

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78084-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)	1.8 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	6.7 mL in 100 mL
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)	1.8 g in 100 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78084-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78084-001-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:78084-001-03	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

OXYGEL ALOE VERA
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78084-002
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)	3 g in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	5 mL in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	3 mL in 100 mL
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)	5 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78084-002-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2020
2	NDC:78084-002-02	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2020
3	NDC:78084-002-03	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/22/2020

Labeler - Matilde Gómez López (951577135)

Registrant - Matilde Gómez López (951577135)

Name	Address	ID/FEI	Business Operations
Establishment
Matilde Gómez López		951577135	manufacture(78084-001, 78084-002) , pack(78084-001, 78084-002) , label(78084-001, 78084-002)