SAUBER KARE 500ml by SSN Solutions LLC / Korea Medicare Co., Ltd. SAUBER KARE 500ml

SAUBER KARE 500ml by

Drug Labeling and Warnings

SAUBER KARE 500ml by is a Otc medication manufactured, distributed, or labeled by SSN Solutions LLC, Korea Medicare Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAUBER KARE 500ML- alcohol gel 
SSN Solutions 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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SAUBER KARE 500ml

Active ingredient

Ethanol 70%

Uses

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

Purpose

Antibacterial

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

avoid contact with 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 (1-800-222-1222) 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.

Inactive ingredients

Glycerin, Carbomer, Triethanol Amine, Aloe extract, Lemon oil, Purified water.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

SAUBER KARE 500ml

SAUBER KARE 500ML 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80704-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
LEMON OIL (UNII: I9GRO824LL)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80704-100-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	10/02/2020	10/02/2020

Labeler - SSN Solutions LLC (116677552)

Establishment
Name	Address	ID/FEI	Business Operations
Korea Medicare Co., Ltd.		695832135	manufacture(80704-100)

Revised: 10/2020

Document Id: b11ec687-728e-189f-e053-2a95a90af078

34390-5

Set id: b0b6c8ae-8d68-66b5-e053-2995a90a260f

Version: 2

Effective Time: 20201007