Disinfectant Sprays by Gemmytec (Shanghai) Co., Ltd / A03 Lab of BTS / Shanghai Chuangshi Industry Group Co., Ltd Gemmytec EA 75% LIQ 60mL

Disinfectant Sprays by

Drug Labeling and Warnings

Disinfectant Sprays by is a Otc medication manufactured, distributed, or labeled by Gemmytec (Shanghai) Co., Ltd, A03 Lab of BTS, Shanghai Chuangshi Industry Group Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DISINFECTANT SPRAYS- ethyl alcohol liquid 
Gemmytec (Shanghai) Co., Ltd

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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Gemmytec EA 75% LIQ 60mL

Active Ingredient(s)

Ethyl alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antibacterial

Use

Disinfectant spray to help reduce bacteria on the skin.

Warnings

HIGHLY FLAMMABLE. Keep away from fire or flame.

Do not use

For external use only.

When using this product do not use in or near the eyes. If case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

• Spray proper amount of disinfectant spray on your hands.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store at 68-77℉(20-25℃).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Glycerin, Fragrance.

Package Label - Principal Display Panel

DISINFECTANT SPRAYS 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81343-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	45 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
LEMON OIL (UNII: I9GRO824LL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81343-121-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/23/2020	12/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/23/2020	12/29/2020

Labeler - Gemmytec (Shanghai) Co., Ltd (554552122)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Industry Group Co., Ltd		546872672	manufacture(81343-121)

Revised: 12/2020

Document Id: b79a11f2-934c-6a29-e053-2a95a90ae610

34390-5

Set id: b723e904-6b45-1b99-e053-2a95a90a599b

Version: 2

Effective Time: 20201229