SANICOP by vinicop s.a. de c.v. SANICOP- alcohol gel

SANICOP by

Drug Labeling and Warnings

SANICOP by is a Otc medication manufactured, distributed, or labeled by vinicop s.a. de c.v.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Alcohol 67% 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

Do not use:

· in children less than 2 months of age

· on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

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 15-30ºC (59-86ºF)

· Avoid freezing and excessive heat above 40ºC (104ºF)

Inactive ingredients

Glyceryn, Water, TEA, Carbomer

PRINCIPAL DISPLAY PANEL

1L NDC: 77208-001-05

1L NDC: 77208-001-07

1L NDC: 77208-001-06

3.78L NDC: 77208-001-04

19L NDC: 77208-001-03

200L NDC: 77208-001-02

1000L NDC: 77208-001-01

INGREDIENTS AND APPEARANCE

SANICOP 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77208-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77208-001-01	1000000 mL in 1 TANK; Type 0: Not a Combination Product	03/01/2020
2	NDC: 77208-001-02	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/01/2020
3	NDC: 77208-001-03	19000 mL in 1 PAIL; Type 0: Not a Combination Product	03/01/2020
4	NDC: 77208-001-04	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2020
5	NDC: 77208-001-05	1000 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/01/2020
6	NDC: 77208-001-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2020
7	NDC: 77208-001-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2020

Labeler - vinicop s.a. de c.v. (812841093)

Establishment
Name	Address	ID/FEI	Business Operations
vinicop s.a. de c.v.		812841093	manufacture(77208-001)