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NDC 15435-0200-04 Suzanne Organics Moisturizing Hand Sanitizer 0.64 mL/mL Details

Suzanne Organics Moisturizing Hand Sanitizer 0.64 mL/mL

Suzanne Organics Moisturizing Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by SLC Skincare. The primary component is ALCOHOL.

Product Information

NDC	15435-0200
Product ID	15435-200_c1884191-191a-981a-e053-2995a90accf2
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	Suzanne Organics Moisturizing Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.64
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
Labeler Name	SLC Skincare
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 15435-0200-04 (15435020004)

Pricing Information	N/A
NDC Package Code	15435-200-04
Billing NDC	15435020004
Package	120 mL in 1 BOTTLE (15435-200-04)
Marketing Start Date	2020-05-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 62b3525b-9d41-470c-97f6-89035fbb39d4 Details

Drug Facts

Active Ingredient

Ethyl Alcohol 64%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only.

Flammable. Keep away from heat and flame.

When using this product

avoid contact with face, eyes, and broken skin. In case of eye contact, flush with plenty of water and seek medical advice.

Stop use and ask a doctor if

irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center.

Directions

Pump into hands, wetting thoroughly, with produ ct. R ub into skin un til dry.
Children under 6 years of age should be supervised by an adult when using this product.

Inactive Ingredients:

Purified Water (Aqua), Propanediol, Hydroxyethylcellulose, Isopropyl Myristate, Citrus Limonum Oil*, Eugenia Caryophyllus Bud Oil, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Juice*, AminoMethyl Propanol, Rosmarinus Officinalis Leaf Oil, Cinnamomum Zeylanicum Bark Oil. *Organic

Package Labeling:

INGREDIENTS AND APPEARANCE

SUZANNE ORGANICS MOISTURIZING HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15435-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.64 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CLOVE OIL (UNII: 578389D6D0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ROSEMARY OIL (UNII: 8LGU7VM393)
CINNAMON BARK OIL (UNII: XE54U569EC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15435-200-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/11/2020

Labeler - SLC Skincare (117453517)

Revised: 5/2021

Document Id: c1884191-191a-981a-e053-2995a90accf2

Set id: 62b3525b-9d41-470c-97f6-89035fbb39d4

Version: 2

Effective Time: 20210504