LINGRUI HAND ANTISEPTIC RINSE FREE- hand sanitizer gel

Lingrui Hand Antiseptic Rinse Free by

Drug Labeling and Warnings

Lingrui Hand Antiseptic Rinse Free by is a Otc medication manufactured, distributed, or labeled by Henan Lingrui Biopharmaceutical Co., Ltd, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethanol 68% v/v. Purpose: Antiseptic

Purpose

For hygienic hand antisepsis.

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.

1. Only external use, oral administration is prohibited.

2. Keep out of reach of children.

3. Those who are allergic to this product (alcohol, ethanol) are contraindicated.

Do not use

• on children less than 2 months of age
• on open skin wounds
• in the eyes. in case of contact, rinse eyes thoroughly with water

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 and redness develop and persist for more than 72 hours.

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

Apply appropriate amount of this product to wash both hands and scrub for 1-3mins.

Other information

Store in sealed, cool and dark condition.

Inactive ingredients

Purified Water, Glycerol, Carbomer, Trolamine, Triclosan.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LINGRUI HAND ANTISEPTIC RINSE FREE 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42217-0110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	40.6 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TRICLOSAN (UNII: 4NM5039Y5X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42217-0110-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

LINGRUI HAND ANTISEPTIC RINSE FREE 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42217-0115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	340 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TRICLOSAN (UNII: 4NM5039Y5X)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42217-0115-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/27/2020

Labeler - Henan Lingrui Biopharmaceutical Co., Ltd (528000440)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Henan Lingrui Biopharmaceutical Co., Ltd		528000440	label(42217-0115, 42217-0110) , manufacture(42217-0115, 42217-0110)