Sani Kare by Beaming White LLC SANI KARE Eucalptus

Sani Kare by

Drug Labeling and Warnings

Sani Kare by is a Otc medication manufactured, distributed, or labeled by Beaming White LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANI KARE- 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.

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SANI KARE Eucalptus

Active Ingredient(s)

Ethyl Alcohol 68% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to reduce bacterial organisms on the skin.

Warnings

Flammable. Keep away from heat 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. 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 develops and persists.

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.

Inactive ingredients

Water, Glycerin, Eucalyptus Oil, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Triethanolamine

Package Label - Principal Display Panel

SANI KARE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75669-0111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)	0.1 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)	0.25 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	28.65 mL  in 100 mL
EUCALYPTUS OIL (UNII: 2R04ONI662)	2 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75669-0111-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/17/2020	03/31/2022

Labeler - Beaming White LLC (019910700)

Registrant - Beaming White LLC (019910700)

Establishment
Name	Address	ID/FEI	Business Operations
Beaming White LLC		019910700	manufacture(75669-0111) , label(75669-0111)

Revised: 1/2022

Document Id: d6ad70f7-88aa-39c8-e053-2995a90ae4ac

34390-5

Set id: aa84f161-cce3-d21d-e053-2995a90a4550

Version: 4

Effective Time: 20220128