HAND SANITIZER SAYFE- alcohol solution

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by M3 Group LLC, Guangzhou Berfly Cosmetic Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HAND SANITIZER  SAYFE
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74176-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74176-001-08	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/24/2020

Labeler - M3 Group LLC (104248779)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Berfly Cosmetic Co., Ltd		553098664	manufacture(74176-001)