OTC Medication Information: Koala Hand Sanitizer Peppermint

KOALA HAND SANITIZER PEPPERMINT- alcohol gel
Beaming White 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.

Active Ingredient(s)

Ethyl Alcohol 68% v/v. Purpose: Antiseptic

2oz Label
(click image for full-size original)

Purpose

Antiseptic

Use

Hand Sanitizer to reduce bacterial organisms on the skin.

Warnings

Flammable. Keep away from fire or flame

Do not use

For external use only.

Avoid contact with eyes. If contact occurs, flush eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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

Directions

  • Dispense a small amount onto palm of hand and rub briskly and thoroughly over surfaces of both hands until dry.
  • Children under 6 years of age should be supervised while using this product.

Other information

  • Store below 110 °F (43 °C)
  • May discolor certain fabrics or surfaces.

Stop use and ask a doctor if irritation or rash develops and persists.

Inactive ingredients

Water, Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Mentha Piperita (Peppermint Oil), Triethanolamine

Package Label — Principal Display Panel

LABEL

KOALA HAND SANITIZER PEPPERMINT
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75669-0201
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 68 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TRIETHANOLAMINE DODECYLBENZENESULFONATE 0.1 mL in 100 mL
GLYCERIN 1 mL in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 0.25 mL in 100 mL
WATER 28.65 mL in 100 mL
PEPPERMINT OIL 2 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75669-0201-1 60 mL in 1 BOTTLE None
2 NDC:75669-0201-6 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 07/17/2020
Labeler — Beaming White LLC (019910700)
Registrant — Beaming White LLC (019910700)
Establishment
Name Address ID/FEI Operations
Beaming White LLC 019910700 manufacture (75669-0201), label (75669-0201)

Revised: 07/2020 Beaming White 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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