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NDC 80704-0101-01 SAUBER KARE 1 gallon 70 mL/100mL Details

SAUBER KARE 1 gallon 70 mL/100mL

SAUBER KARE 1 gallon is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by SSN Solutions LLC. The primary component is ALCOHOL.

Product Information

NDC	80704-0101
Product ID	80704-101_d4f22f3f-9b2e-5c09-e053-2a95a90a2a73
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SAUBER KARE 1 gallon
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	SSN Solutions LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 80704-0101-01 (80704010101)

Pricing Information	N/A
NDC Package Code	80704-101-01
Billing NDC	80704010101
Package	3780 mL in 1 BOTTLE (80704-101-01)
Marketing Start Date	2020-10-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b0b88536-1466-9336-e053-2995a90a39f0 Details

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 1 gallon

INGREDIENTS AND APPEARANCE

SAUBER KARE 1 GALLON

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80704-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80704-101-01	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2020

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

Labeler - SSN Solutions LLC (116677552)

Name	Address	ID/FEI	Business Operations
Establishment
Korea Medicare Co., Ltd.		695832135	manufacture(80704-101)

Revised: 1/2022

Document Id: d4f22f3f-9b2e-5c09-e053-2a95a90a2a73

Set id: b0b88536-1466-9336-e053-2995a90a39f0

Version: 2

Effective Time: 20220106