BIO GLOW ANTISEPTIC HAND SANITIZER GEL

Bio Glow Antiseptic Hand Sanitizer Gel by

Drug Labeling and Warnings

Bio Glow Antiseptic Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Aztec Finance Corporation Limited, European Perfume Works Co. (L.L.C)., SUNTARA COSMETICS PRIVATE LIMITED, Suntara Cosmetics Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BIO GLOW ANTISEPTIC HAND SANITIZER GEL- ethyl alcohol gel 
Aztec Finance Corporation Limited

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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BIO GLOW ANTISEPTIC HAND SANITIZER GEL

Drug Facts

Active ingredient

Ethyl alcohol 62% v/v

Purpose

Antiseptic

Uses

■ hand sanitizer to decrease bacteria on the skin

■ recommended for repeated use

■ for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

■ in children less than 2 months of age

■ on open skin wounds

When using this product ■ do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

■ irritation and redness develop

■ condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ place a smaller amount (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds)

■ supervise children under 6 years of age when using this product to avoid swallowing

Other information

■ store between 15-30°C (59-86°F)

■ avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

aloe vera (Aloe barbadensis) leaf juice, aminomethyl propanol, carbomer, fragrance, glycerin, limonene, tocopheryl acetate, water

Questions? +1-210-340-6300

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

VITAMIN E

REFRESHING FRAGRANCE

NON STICKY

SOFT ON HANDS

Distributed By: ARION PERFUME & BEAUTY,INC., Suite 216, 1800 NE

Loop 410, San Antonio, TX 78217, USA

Manufactured By: EUROPEAN PERFUME WORKS CO. L.L.C.,

PO BOX 23121, SHARJAH , UAE.

Made in United Arab Emirates

Manufactured By: SUNTARA COSMETICS PVT LTD,

MEPZ Special Economic Zone (SEZ), Tambaram, Chennai-600045, Tamil Nadu, India

MFG. Lic. No. TN00005803

Manufactured By: SUNTARA COSMETICS PVT LTD,

I2-& I4, Indraprasth Industrial & Logistic Park, Kheda-387550, Gujarat, India

Made in India

Packaging

BIO GLOW ANTISEPTIC HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80118-202
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)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80118-202-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
2	NDC: 80118-202-02	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
3	NDC: 80118-202-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
4	NDC: 80118-202-04	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
5	NDC: 80118-202-05	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
6	NDC: 80118-202-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
7	NDC: 80118-202-07	330 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
8	NDC: 80118-202-08	485 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
9	NDC: 80118-202-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021
10	NDC: 80118-202-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020	12/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020	12/24/2021

Labeler - Aztec Finance Corporation Limited (851738210)

Establishment
Name	Address	ID/FEI	Business Operations
EUROPEAN PERFUME WORKS CO. LLC		864294207	manufacture(80118-202)

Establishment
Name	Address	ID/FEI	Business Operations
Suntara Cosmetics Private Limited		856844952	manufacture(80118-202)

Revised: 12/2021

Document Id: ca06579a-c495-453e-a9ad-0a1689ae9129

34390-5

Set id: ec6e99c7-5997-4ce0-b122-77f2bec83ed1

Version: 3

Effective Time: 20211224