DailyMed - SANUS STERILE SAFETY SET- sterile safety set kit

Contains inactivated NDC Code(s)
NDC Code(s): 76557-002-01, 79764-000-01
Packager: SANUS SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETI

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated July 28, 2020

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Active Ingredient
70% Isopropyl Alcohol in swab(wipe).

70% Isopropyl Alcohol in swab(wipe).
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Directions (Swab)
Wet hands thoroughly with product and allow to dry. When finished, discard wipe in trash receptacle. Do not flush. Supervise children under 6 years of age when using this product to avoid ...

Wet hands thoroughly with product and allow to dry. When finished, discard wipe in trash receptacle. Do not flush. Supervise children under 6 years of age when using this product to avoid swallowing.
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Warnings
Flammable. Keep away from heat or flame.

Flammable. Keep away from heat or flame.
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Inactive Ingredients
Purified water USP.

Purified water USP.
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INDICATIONS & USAGE

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

If swallowed, get medical help or contact a Poison Control Center right away.
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Purpose (Swab)
Antiseptic Cleanser

Antiseptic Cleanser
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Sterile Set
Surgical Mask 1 PCS - Alcohol Swab 6*8: 2 PCS - Nitrile Glove M: 2 PCS

Surgical Mask 1 PCS

Alcohol Swab 6*8: 2 PCS

Nitrile Glove M: 2 PCS
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PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE

Product Information

SANUS STERILE SAFETY SET sterile safety set kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79764-000

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79764-000-01	1 in 1 PACKAGE, COMBINATION; Type 1: Convenience Kit of Co-Package	07/28/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1		1
Part 2		2
Part 3	2 PATCH	2 mL

Part 1 of 3

RORO HEALTHCARE DISPOSABLE FACE MASK RORO MEDICAL DISPOSABLE FACE MASK face mask (except n95 respirator) for general public/healthcare personnel per iie guidance cloth

Product Information
Route of Administration	TOPICAL

Ingredient Name	Strength
Inactive Ingredients
POLYPROPYLENE (30000 MW) (UNII: T71QXI2O62)	66

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	C48623	07/28/2020

Part 2 of 3

DISPOSABLE NITRILE EXAMINATION GLOVE polymer patient examination glove cloth

Product Information
Route of Administration	TOPICAL

Ingredient Name	Strength
Inactive Ingredients
ACRYLONITRILE (UNII: MP1U0D42PE)	100

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	LZA	07/28/2020

Part 3 of 3

JUNIPER CLEAN ALCOHOL SWAB 70% alcohol swab swab

Product Information
Item Code (Source)	NDC:76557-002
Route of Administration	TOPICAL, CUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76557-002-01	1 mL in 1 PATCH; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/28/2020

Labeler - SANUS SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETI (533144738)

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	RxCUI	RxNorm NAME	RxTTY
1	797544	isopropyl alcohol 70 % Medicated Pad	PSN
2	797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD
3	797544	isopropyl alcohol 70 % Medicated Pad	SY
4	797544	isopropyl alcohol 70 % Topical Cloth	SY
5	797544	isopropyl alcohol 70 % Topical Swab	SY

Label: SANUS STERILE SAFETY SET- sterile safety set kit

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	NDC
1	76557-002-01
2	79764-000-01 (inactivated)

Label: SANUS STERILE SAFETY SET- sterile safety set kit

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SANUS STERILE SAFETY SET- sterile safety set kit

Number of versions: 1

SANUS STERILE SAFETY SET- sterile safety set kit

SANUS STERILE SAFETY SET- sterile safety set kit

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SANUS STERILE SAFETY SET- sterile safety set kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.