SANICOP HAND SANITIZER- alcohol gel

SANICOP HAND SANITIZER by

Drug Labeling and Warnings

SANICOP HAND SANITIZER 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 INGREDIENT

Alcohol 67% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

· 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.

STORAGE AND HANDLING

· Store between 15-30ºC (59-86ºF)

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

INACTIVE INGREDIENT

Glyceryn, Water, TEA, HEC

PRINCIPAL DISPLAY PANEL

.236 L NDC: 77208-002-06

.473 L NDC: 77208-002-05

1 L NDC: 77208-002-04

19 L NDC: 77208-002-03

200 L NDC: 77208-002-02

1000 L NDC: 77208-002-01

INGREDIENTS AND APPEARANCE

SANICOP HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77208-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77208-002-01	1000 L in 1 TANK; Type 0: Not a Combination Product	04/01/2020
2	NDC: 77208-002-02	200 L in 1 DRUM; Type 0: Not a Combination Product	04/01/2020
3	NDC: 77208-002-03	19 L in 1 PAIL; Type 0: Not a Combination Product	04/01/2020
4	NDC: 77208-002-04	1 L in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
5	NDC: 77208-002-05	0.473 L in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020
6	NDC: 77208-002-06	0.236 L in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
vinicop s.a. de c.v.		812841093	manufacture(77208-002)