OTC Medication Information: Hand Sanitizer

HAND SANITIZER- alcohol gel
CA-Botana International

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) (80%, 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. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 65% 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

purified water USP, Aloe barbadensis extract, Hamamelis virginiana (Whitchhazel) extract, Polyquaternium-37, Cucumis sativus (Cucumber) extract, Centella asiatica (Gotu kola) extract, Equisetum fluviatitile (Horsetail) extract, Rosmarinus officinalis (Rosemary) extract, Aesculus hippocastanum (Horse chestnut) extract, Camellia sinensis (Green tea) extract, Olea europaea (Olive) extract, Eucalyptus globulus extract, Propanediol, Phenoxyethanol, Potassium Sorbate, Ethylhexylglycerin, Sodium Phytate, Benzalkoniun Chloride.

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HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 65 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CAMELLIA SINENSIS WHOLE
PROPANEDIOL
POTASSIUM SORBATE
EQUISETUM FLUVIATILE WHOLE
ROSEMARY
HEXASODIUM PHYTATE
CENTELLA ASIATICA LEAF
HORSE CHESTNUT
WITCH HAZEL
BENZALKONIUM CHLORIDE
POLYQUATERNIUM 37 (200 MPA.S)
GREEN OLIVE
ALOE VERA LEAF
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
CUCUMBER
EUCALYPTUS GLOBULUS LEAF
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35192-031-12 3785 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 04/10/2020
Labeler — CA-Botana International (106276728)
Registrant — Rodolfo Ugelstad (106276728)
Establishment
Name Address ID/FEI Operations
CA Botana International 106276728 manufacture (35192-031)

Revised: 01/2021 CA-Botana International

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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