OTC Medication Information: A2A Elite 8oz Gel Hand Sanitizer

A2A ELITE 8OZ GEL HAND SANITIZER- alcohol gel
SunBeam Laboratories 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.

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Water (26.28% v/v),
  3. Alkyl Acrylate (3.00% v/v).,
  4. Isopropyl Alcohol (0.4% v/v),
  5. Glycerin (0.18% v/v),
  6. Aminomethyl Propanol (0.01% v/v),
  7. Glycol (0.10% v/v),
  8. Isopropyl Miristrate (0.01% v/v),
  9. Aloe (0.01% v/v),
  10. Vitamin E (0.01% v/v).

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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 children less than 2 months of age
  • 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 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.

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.

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 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water (26.28% v/v), Alkyl Acrylate (3.00% v/v)., Isopropyl Alcohol (0.4% v/v), Glycerin (0.18% v/v), Aminomethyl Propanol (0.01% v/v), Glycol (0.10% v/v), Isopropyl Miristrate (0.01% v/v), Aloe (0.01% v/v), Vitamin E (0.01% v/v).

Package Label — Principal Display Panel

8oz A2A Gel
(click image for full-size original)

A2A ELITE 8OZ GEL HAND SANITIZER
a2a elite 8oz gel hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75321-1308
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 165.61 mL in 236.59 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 7.1 mL in 236.59 mL
ISOPROPYL ALCOHOL 0.95 mL in 236.59 mL
WATER 62.18 mL in 236.59 mL
ISOPROPYL MYRISTATE 0.02 mL in 236.59 mL
ALOE VERA LEAF 0.02 mL in 236.59 mL
.ALPHA.-TOCOPHEROL 0.02 mL in 236.59 mL
GLYCERIN 0.43 mL in 236.59 mL
AMINOMETHYLPROPANOL 0.02 mL in 236.59 mL
CAPRYLYL GLYCOL 0.24 mL in 236.59 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75321-1308-5 236.59 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — SunBeam Laboratories LLC (105139335)
Establishment
Name Address ID/FEI Operations
SunBeam Laboratories LLC 105139335 manufacture (75321-1308)

Revised: 08/2020 SunBeam Laboratories 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.

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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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