ADVANCED GEL HAND SANITIZER REFRESHING CITRUS- ethanol alcohol gel

Advanced Gel Hand Sanitizer Refreshing Citrus by

Drug Labeling and Warnings

Advanced Gel Hand Sanitizer Refreshing Citrus by is a Otc medication manufactured, distributed, or labeled by BLUETRACK, Inc., NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.LTD, NINGBO OCEANSTAR CHEMICAL PRODUCTS CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethanol Alcohol 62% . Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

For Sanitizing hands to reduce bacteria and virus on the skin

Warnings

Flammable. Keep away from fire or flame

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of childrens or pets.

WHEN USING

Do not put in eyes

Directions

Apply Small amount in your palm and briskly rub hands together until dry.

Inactive ingredients

Water, Glycerin, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Vitamin E, Iron Oxide(CI 77499),Iron Oxide(CI 77492), D&C Red No.30.

Package Label - Principal Display Panel

5000 mL NDC: 81209-100-01

1000mL NDC: 81209-100-02

30mL NDC :81209-100-03

30mL promotional NDC :81209-100-04

60mL NDC :81209-100-05

60mL Promotional NDC: 81209-100-06

INGREDIENTS AND APPEARANCE

ADVANCED GEL HAND SANITIZER REFRESHING CITRUS 
ethanol alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81209-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
TOCOPHEROL (UNII: R0ZB2556P8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
D&C RED NO. 30 (UNII: 2S42T2808B)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81209-100-01	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020
2	NDC: 81209-100-02	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2020
3	NDC: 81209-100-03	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/01/2021
4	NDC: 81209-100-04	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/01/2021
5	NDC: 81209-100-05	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/01/2021
6	NDC: 81209-100-06	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2020

Labeler - BLUETRACK, Inc. (135029937)

Registrant - NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.LTD (544493972)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO LTD		544493972	manufacture(81209-100)