RRS-KEY1 by SUMEC Hardware & Tools Co., Ltd. / A03 Lab of BTS RRS-KEY1- alcohol gel

RRS-KEY1 by

Drug Labeling and Warnings

RRS-KEY1 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]

Active Ingredient(s)

Ethyl alcohol 80% 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

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Place enough product into storage case until both pieces of sponge are saturated.
• 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, Sodium Hyaluronate, Acrylic Acid Polymers, Trolamine, Denatonium, Water (aqua)

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

RRS-KEY1 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74035-1061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	47.2 mL  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74035-1061-6	100 in 1 CARTON	07/15/2020
1	NDC: 74035-1061-1	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/15/2020

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(74035-1061) , label(74035-1061)