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

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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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:

· 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.

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

.473 L NDC: 77208-001-09

SANICOP LABEL .473 L BOTTLE

.236L NDC: 77208-001-10

SANICOP LABEL .236 L BOTTLE

1L NDC: 77208-001-05 SANICOP LABEL 1L AP

1L NDC: 77208-001-07 SANICOP LABEL 1L BOTTLE

1L NDC: 77208-001-06 SANICOP LABEL 1L DOSIF

3.78L NDC: 77208-001-04 SANICOP LABEL 3.78L

19L NDC: 77208-001-03 SANICOP LABEL 19L

200L NDC: 77208-001-02 SANICOP LABEL 200L

1000L NDC: 77208-001-01 SANICOP LABEL 1000L

SANICOP 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77208-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL67 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77208-001-011000000 mL in 1 TANK; Type 0: Not a Combination Product03/01/2020
2NDC:77208-001-02200000 mL in 1 DRUM; Type 0: Not a Combination Product03/01/2020
3NDC:77208-001-0319000 mL in 1 PAIL; Type 0: Not a Combination Product03/01/2020
4NDC:77208-001-043780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2020
5NDC:77208-001-051000 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/01/2020
6NDC:77208-001-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2020
7NDC:77208-001-071000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
8NDC:77208-001-09473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
9NDC:77208-001-10236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/01/2020
Labeler - vinicop s.a. de c.v. (812841093)
Establishment
NameAddressID/FEIBusiness Operations
vinicop s.a. de c.v.812841093manufacture(77208-001)

Revised: 5/2020
Document Id: a61cdeae-db65-2db2-e053-2a95a90a266b
Set id: a48e5405-67ec-2e57-e053-2995a90a498b
Version: 2
Effective Time: 20200520
 
vinicop s.a. de c.v.