Antiseptic Hand Sanitizer

Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by La Bottega Dell'Albergo USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISEPTIC HAND SANITIZER- alcohol gel 
La Bottega Dell'Albergo USA, 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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Antiseptic Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

  • For hand washing to decrease bacteria on the skin

Warnings

  • For external use only

Flammable. Keep away from heat or flame.

Do not use

in the eyes

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

Inactive ingredients

Carbomer, glycerin,thyme (Thymus vulgaris) leaf oil, triethanolamine,water (aqua).

Package Labeling

Box2Bottle2

Package Labeling:40ml

Label

ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77669-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
THYME OIL (UNII: 2UK410MY6B)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77669-001-02216 in 1 BOX07/25/202012/31/2022
140 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 77669-001-0130 in 1 BOX09/30/202012/31/2022
240 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/25/202012/31/2022
Labeler - La Bottega Dell'Albergo USA, Inc. (027470635)

Revised: 12/2021
Document Id: d454dca6-7c2d-7de3-e053-2995a90a1c25
Set id: 1f585c11-415d-463c-be0d-63e79876a945
Version: 4
Effective Time: 20211229