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

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BIO GLOW ANTISEPTIC HAND SANITIZER GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80118-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80118-202-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
2NDC: 80118-202-0295 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
3NDC: 80118-202-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
4NDC: 80118-202-04200 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
5NDC: 80118-202-05236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
6NDC: 80118-202-06250 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
7NDC: 80118-202-07330 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
8NDC: 80118-202-08485 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
9NDC: 80118-202-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
10NDC: 80118-202-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/202012/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/07/202012/24/2021
Labeler - Aztec Finance Corporation Limited (851738210)
Establishment
NameAddressID/FEIBusiness Operations
EUROPEAN PERFUME WORKS CO. LLC864294207manufacture(80118-202)
Establishment
NameAddressID/FEIBusiness Operations
Suntara Cosmetics Private Limited856844952manufacture(80118-202)

Revised: 12/2021