ANTISEPTIQUE ADVANCE STRENGTH- alcohol spray 
Hubot Healthcare LLC

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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Antiseptique Advance Strength

Drug Facts

Active ingredient

Ethyl Alcohol 80% v/v

Purposes

Antiseptic handwash

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Do not use

  • In eyes | on children less than 2 months old | on open skin wounds

When using this product

  • Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if skin irritation or rash occurs. There may be signs of a serious conditions.

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

Directions

Other Information

Inactive Ingredients

Purified Water USP, Glycerin, Hydrogen Peroxide

Questions?

Email: sales@tri-pac.us

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label

ANTISEPTIQUE+
ADVANCED STRENGTH
sanitizer mist

Alcohol Antiseptic 80%
Topical Non-sterile Solution

2 FL. OZ. (59 ML)

PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label
ANTISEPTIQUE ADVANCE STRENGTH 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72138-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Hydrogen Peroxide (UNII: BBX060AN9V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72138-420-2059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2020
2NDC:72138-420-40118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2020
3NDC:72138-420-60177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/20/2020
4NDC:72138-420-16472 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E03/19/2020
Labeler - Hubot Healthcare LLC (081084880)

Revised: 3/2020
Document Id: 3cd7a637-6efb-455c-a723-6b7316084790
Set id: 28569ea5-29dc-4194-a898-cd7d0f44c24e
Version: 1
Effective Time: 20200325
 
Hubot Healthcare LLC