ADVANCED GEL HAND SANITIZER REFRESHING CITRUS- ethanol alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
BLUETRACK, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic, Hand Sanitizer For Sanitizing hands to reduce bacteria and virus on the skin
Authorization status:
OTC monograph not final
Authorization number:
81209-100-01, 81209-100-02, 81209-100-03, 81209-100-04, 81209-100-05, 81209-100-06

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ADVANCED GEL HAND SANITIZER REFRESHING CITRUS- ethanol alcohol gel

BLUETRACK, Inc.

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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Advanced Gel HAND SANITIZER Refreshing Citrus

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 childrens or pets.

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

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 g in 112 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

BLUETRACK, Inc.

Name

Address

ID/FEI

Business Operations

NINGBO OCEANSTAR CHEMICAL PRODUCTS CO LTD

544493972

manufacture(81209-100)

Revised: 5/2021

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