OTC Medication Information: Antiseptique Advance Strength

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.

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

  • For external use only
  • Flammable, keep away from heat or flame.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry. 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

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
(click image for full-size original)
ANTISEPTIQUE ADVANCE STRENGTH
alcohol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72138-420
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 80 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Hydrogen Peroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72138-420-20 59 mL in 1 BOTTLE, SPRAY None
2 NDC:72138-420-40 118 mL in 1 BOTTLE, SPRAY None
3 NDC:72138-420-60 177 mL in 1 BOTTLE, SPRAY None
4 NDC:72138-420-16 472 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 03/19/2020
Labeler — Hubot Healthcare LLC (081084880)

Revised: 03/2020 Hubot Healthcare LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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