Hand Sanitizer by Newacme LLC / SHANDISHI Biological Technology Co., Ltd. Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Newacme LLC, SHANDISHI Biological Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Newacme 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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Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

For handwashing to decrease bacteria ont he skin.

Warnings

Flammable. Keep away from fire or flame.

For External Use Only

When using this product

avoid contact with eyes. If contact occurs rinse eyes thoroughly with water.

Stop use and ask a doctor

if skin irritation or rash develops and continues for more than 72 hours.

Keep out of reach of children.

If swallowed get medical help or contact your Poison Control right away.

Directions

• Place enough product in your palm to thoroughly cover your hands.
• Children under 6 year of age should be supervised when using this product.
• Rub hands together briskly until dry.
• Not recommended for infants.

Other information

• Do not store above 105°F.
• Discolor some fabrics.
• Harmful to wood finishes and plastics.

Inactive ingredients

Aloe vera leaf juice, Glycerin, Fragrance(Parfum), Water

Package Labeling:

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74341-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74341-003-03	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2020	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/20/2020	01/01/2022

Labeler - Newacme LLC (117465743)

Establishment
Name	Address	ID/FEI	Business Operations
SHANDISHI Biological Technology Co., Ltd.		411868994	manufacture(74341-003)

Revised: 1/2022

Document Id: d6a6f98e-db89-c8e8-e053-2a95a90ad516

34390-5

Set id: 59690973-ee33-4800-8357-e5ef27b2d24c

Version: 2

Effective Time: 20220128