SUMEC, Hand Sanitizer, Gel, 2.2% Ethyl alcohol, 473mL

SUPPLYAID Hand sanitizer RRS-HS16B by

Drug Labeling and Warnings

SUPPLYAID Hand sanitizer RRS-HS16B by is a Otc medication manufactured, distributed, or labeled by SUMEC Hardware & Tools Co., Ltd., A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLYAID HAND SANITIZER RRS-HS16B- alcohol gel 
SUMEC Hardware & Tools Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SUMEC, Hand Sanitizer, Gel, 2.2% Ethyl alcohol, 473mL

Active Ingredient(s)

Alcohol 2.2% 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

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

Do not use

• on 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 59-86℉ (15-30℃)
• Avoid freezing and excessive heat above 104℉ (40℃)

Inactive ingredients

Glycerol, Aloe extract, Water (aqua)

Package Label - Principal Display Panel

SUPPLYAID HAND SANITIZER RRS-HS16B 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74035-1012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.419 g  in 473 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	10.406 mL  in 473 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2365 mL  in 473 mL
WATER (UNII: 059QF0KO0R)	458.5735 mL  in 473 mL
GLYCERIN (UNII: PDC6A3C0OX)	2.365 mL  in 473 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74035-1012-3	20 in 1 BOX	04/10/2020	04/17/2020
1	NDC: 74035-1012-1	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/10/2020	04/17/2020

Labeler - SUMEC Hardware & Tools Co., Ltd. (654687771)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
SUMEC Hardware & Tools Co., Ltd.		654687771	manufacture(74035-1012) , label(74035-1012)

Revised: 4/2020

Document Id: a36df4a2-6f05-4ad3-e053-2a95a90a8f03

34390-5

Set id: a2b9e4aa-6485-c9ac-e053-2a95a90a8ece

Version: 2

Effective Time: 20200417

 

SUMEC Hardware & Tools Co., Ltd.