ADVANCED GEL HAND SANITIZER SOOTHING LAVENDER- 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 Soothing Lavender

Active Ingredient(s)

Ethanol Alcohol 62% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Advanced Hand Sanitizer Soothing Lavender

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 or pets.

Do not put in eyes

Directions

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

Inactive ingredients

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

60mL NDC : 81209-200-03 60mL

5000 mL NDC: 81209-200-01

1000mL NDC: 81209-200-02

5000mL 1000mL

ADVANCED GEL HAND SANITIZER SOOTHING LAVENDER
ethanol alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81209-200
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 30 (UNII: 2S42T2808B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TOCOPHEROL (UNII: R0ZB2556P8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81209-200-01	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2020
2	NDC:81209-200-02	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/01/2020
3	NDC:81209-200-03	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	04/01/2021

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

Labeler - BLUETRACK INC (135029937)

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

Name	Address	ID/FEI	Business Operations
Establishment
NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.LTD		544493972	manufacture(81209-200)