TRIDENT BIOGUARD ANTISEPTIC HAND SANITIZER GEL

TRIDENT BIOGUARD ANTISEPTIC HAND SANITIZER Gel by

Drug Labeling and Warnings

TRIDENT BIOGUARD ANTISEPTIC HAND SANITIZER Gel by is a Otc medication manufactured, distributed, or labeled by Texan Stone Llc Dba Texan Minerals And Chemicals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRIDENT BIOGUARD ANTISEPTIC HAND SANITIZER GEL- ethyl alcohol gel 
Texan Stone Llc Dba Texan Minerals And Chemicals

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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TRIDENT BIOGUARD ANTISEPTIC HAND SANITIZER GEL

Drug Facts

Active ingredient

Ethyl alcohol 70% 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

• wet hands thoroughly with product and allow to dry without wiping
• 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

water, glycerin, carbopol, aloe vera, aminomethylpropanol, fragrance, hydrogen peroxide, denatonium benzoate, tocopherol, tert-butyl alcohol

Questions? +1-832-457-3695

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

Alcohol Antiseptic 70% Topical Solution Non Sterile Solution

with Aloe vera & Vitamin E Moisturizing

Distributed by : Texan Stone LLC DBA Texan Minerals & Chemicals

12814 Murphy Road, Stafford, TX 77477

Made in India

Packaging

TRIDENT BIOGUARD ANTISEPTIC HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80697-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
TOCOPHEROL (UNII: R0ZB2556P8)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80697-004-33	976 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2021	01/31/2022
2	NDC: 80697-004-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2021	01/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/13/2021	01/31/2022

Labeler - Texan Stone Llc Dba Texan Minerals And Chemicals (017843978)

Revised: 9/2022

Document Id: d58eb3af-6196-402f-8a1b-91ed6e28f16f

34390-5

Set id: c90be71c-06c4-4d55-b8ac-182022584adb

Version: 2

Effective Time: 20220907

 

Texan St