HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ningbo Roni Cosmetic Co., Ltd, A03 Lab of BTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 67% w/w. Purpose: Antimicrobial

Purpose

Antimicrobial.

Use

Uses for handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable, keep away from heat and flame.

Do not use

Do not us in the eyes. In case of contact, rinse eyes troroughly with water.

WHEN USING

When using this product, do not use in or near the eyes or wound.

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

• Dispense product evenly on palms or on material surface and rub your hands until dry.
• Children should be under adult supervision when using this product.
• No dilute required.

Other information

Store at 20℃ to 25℃.

Inactive ingredients

Aqua, Carbomer, Triethanolamine, Aloe barbadensis leaf juice, Tocopherol, Fragrance.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77309-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	43.365 mL  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CLOVE (UNII: K48IKT5321)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77309-101-17	200 in 1 CARTON	05/12/2020
1	NDC: 77309-101-01	59 mL in 1 BOTTLE; 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	05/12/2020

Labeler - Ningbo Roni Cosmetic Co., Ltd (411892769)

Registrant - A03 Lab of BTS (548009541)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Roni Cosmetic Co., Ltd		411892769	manufacture(77309-101) , label(77309-101)