HAND SANITIZER SAYFE- alcohol solution 
M3 Group LLC

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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Sayfe Hand Sanitizer

Active Ingredient

Alcohol 70% v/v

Purpose

Antiseptic

Use

■ hand sanitizer to help reduce bacteria on the skin. For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from fire or flame.

Do not use

■ in children less than 2 months of age ■ on open skin wounds

When using this product

■ avoid getting into the eyes. ■ in case of eye contact immediately flush eyes throughly with water

Stop use and ask a doctor if

■ irritation or redness develops ■ conditions persist for more than 72 hours ■ redness is present

Keep out of reach of children

In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

Directions

■ place enough product in your palm to thoroughly cover both hands ■ rub hands together until dry ■ Supervise children under 6 years of age when using this product to avoid swallowing

Other information

■ do not store above 105ºF ■ may discolor fabrics or surfaces

Inactive Ingredients

water, glycerin, carbomer, aloe extract,sodium hydroxide

Package Label

package label

HAND SANITIZER  SAYFE
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74176-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74176-001-08250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/24/2020
2NDC:74176-001-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/25/2020
3NDC:74176-001-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2020
Labeler - M3 Group LLC (104248779)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Berfly Cosmetic Co., Ltd553098664manufacture(74176-001)

Revised: 5/2020
Document Id: a6a8025b-d606-20ca-e053-2995a90a6f4d
Set id: a40df265-6f90-3010-e053-2a95a90a32d1
Version: 2
Effective Time: 20200527
 
M3 Group LLC