Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol liquid
Atc Scientific, 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.

Hand Sanitizer — 12oz & 32oz

Front Label — 12oz:

front label 12oz
(click image for full-size original)

Front Label — 32oz:

front label 32oz
(click image for full-size original)

Back Label (all sizes):

back label
(click image for full-size original)

Purpose

Antiseptic

Warnings

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

Warnings

For external use only. Keep away from heat or flame

Do not use in children less than 2 months of age

Do not use op 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 irritation or rash occurs. These may be signs of a serious condition.

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

Use(s)

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

Inactive Ingredients

glycerol, hydrogen peroxide, purified water USP

Directions & Other Information

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.

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Isopropyl alcohol 75% v/v

HAND SANITIZER
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74133-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCEROL FORMAL 1.45 mL in 100 mL
HYDROGEN PEROXIDE 0.12 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74133-101-01 354 mL in 1 BOTTLE, PLASTIC None
2 NDC:74133-101-02 946 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 part333A 03/27/2020
Labeler — Atc Scientific, LLC (801189015)
Registrant — Atc Scientific, LLC (801189015)
Establishment
Name Address ID/FEI Operations
Atc Scientific, LLC 801189015 manufacture (74133-101)

Revised: 03/2020 Atc Scientific, LLC

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