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

Flammable, keep away from fire or flame.

For external use only.

Do not use

on open 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

Purified water USP, glycerin, carbomer, triethaanolamine, methylparabene, propylparabene, propylene glycol, DMDM Hydantoin.

Package Label - Principal Display Panel

946 mL NDC: 77143-004-08 Kathari 946 ml

250 mL NDC: 77143-004-01 Etiqueta 250 mL

236 mL NDC: 77143-004-02

236 mL

3785 mL NDC: 77143-004-06

3785 mL

500 mL NDC: 77143-004-03

500 mL

946 mL NDC: 77143-004-05

946 mL

250mL NDC: 77143-004-10

250 mL

3785 mL NDC: 77143-004-11

3785 mL

60 mL NDC: 77143-004-12

60 mL front

60 mL back

125 mL NDC: 77143-004-18

pdp 125 ml vitus

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77143-004
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
GLYCERIN (UNII: PDC6A3C0OX)	2 mL in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.5 g in 100 mL
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)	0.025 g in 100 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.025 g in 100 mL
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.025 g in 100 mL
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)	1 g in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77143-004-01	250 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
2	NDC:77143-004-02	236 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
3	NDC:77143-004-03	473 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
4	NDC:77143-004-05	946 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
5	NDC:77143-004-06	3785 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/30/2020
6	NDC:77143-004-08	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:77143-004-10	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/14/2020
8	NDC:77143-004-11	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:77143-004-12	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC:77143-004-18	125 mL in 1 BOTTLE; 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

Labeler - NATURATLALI S DE RL DE CV (951577202)

Registrant - NATURATLALI S DE RL DE CV (951577202)

Name	Address	ID/FEI	Business Operations
Establishment
NATURATLALI S DE RL DE CV		951577202	pack(77143-004) , manufacture(77143-004) , label(77143-004)

77143-004 - 70% alcohol