SAFE AND CLEAN- hand sanitizer gel 
SNC Industria de Cosmeticos Ltda

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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SNC Industria-SafeSupply Sanitizer GEL

Active Ingredient(s)

Alcohol 75% 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

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

Other information

Avoid freezing and excessive heat above 40C (104F)

May discolor certain fabrics or surfaces

Inactive ingredients

aloe vera extract, glycerin, hydrogen peroxide, carbomer, methylchloroisothiazolinone, trolamine, water, denatonium benzoate

Package Label - Principal Display Panel

250ML NDC: 79990-111-12

250 mL NDC: 79990-111-12

SAFE AND CLEAN 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79990-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79990-111-1160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
2NDC:79990-111-12250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
3NDC:79990-111-13500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
4NDC:79990-111-141000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
5NDC:79990-111-155000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/07/2020
Labeler - SNC Industria de Cosmeticos Ltda (914610642)
Establishment
NameAddressID/FEIBusiness Operations
SNC Industria de Cosmeticos Ltda914610642manufacture(79990-111)

Revised: 8/2020
Document Id: ac4e0e24-928b-b83b-e053-2995a90a996f
Set id: ac4e0e24-9288-b83b-e053-2995a90a996f
Version: 1
Effective Time: 20200807
 
SNC Industria de Cosmeticos Ltda