PURUPURU HAND SANITIZER- alcohol gel

PURUPURU HAND SANITIZER by

Drug Labeling and Warnings

PURUPURU HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Jyoungcosmetic Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

in 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 Posion 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 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Butylene Glycol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexanediol, Triethanolamine, Fragrance (Lime)

Package Label

INGREDIENTS AND APPEARANCE

PURUPURU HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79547-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71.25 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79547-201-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/10/2020
2	NDC: 79547-201-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
3	NDC: 79547-201-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
4	NDC: 79547-201-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
5	NDC: 79547-201-05	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
6	NDC: 79547-201-06	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
7	NDC: 79547-201-07	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/10/2020
8	NDC: 79547-201-08	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
9	NDC: 79547-201-09	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
10	NDC: 79547-201-10	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/10/2020
11	NDC: 79547-201-11	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/10/2020
12	NDC: 79547-201-12	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/10/2020

Labeler - Jyoungcosmetic Inc. (695530307)

Registrant - Jyoungcosmetic Inc. (695530307)

Establishment
Name	Address	ID/FEI	Business Operations
Jyoungcosmetic Inc.		695530307	manufacture(79547-201)