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NDC 70930-0170-01 FINE AND CLEAR ADVANCED HAND SANITIZER 350 mL/500mL Details

FINE AND CLEAR ADVANCED HAND SANITIZER 350 mL/500mL

FINE AND CLEAR ADVANCED HAND SANITIZER is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Natuzen Co.,Ltd.. The primary component is ALCOHOL.

Product Information

NDC	70930-0170
Product ID	70930-170_031f77d3-1cd5-4fde-8e55-92da56e43484
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	FINE AND CLEAR ADVANCED HAND SANITIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	350
Active Ingredient Units	mL/500mL
Substance Name	ALCOHOL
Labeler Name	Natuzen Co.,Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70930-0170-01 (70930017001)

Pricing Information	N/A
NDC Package Code	70930-170-01
Billing NDC	70930017001
Package	500 mL in 1 BOTTLE, SPRAY (70930-170-01)
Marketing Start Date	2020-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 10e8a967-d559-4a18-91d3-dfba845a4871 Details

ACTIVE INGREDIENT

Ethyl alcohol 70%

INACTIVE INGREDIENTS

Water, Butylene Glycol, Polysorbate 20, Aloe Barbadensis Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Sodium Citrate, Citric Acid, Fragrance, Citral, Limonene

PURPOSE

Antiseptic Rub

WARNINGS

• Flammable. Keep away from fire or flame.

• For external use only.

• When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

• Stop use and ask a doctor if irritation or rash appears and lasts.

• Keep Out of Reach of Children.

• Do not eat.

• If swallowed, get medical help or contact a Poison Control Center right away

KEEP OUT OF REACH OF CHILDREN

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

Uses

Hand sanitizer to help reduce bacteria and virus on the skin.

For use when soap and water are not available.

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.

• Children under 6 years of age should be supervised when using. Not recommended for infants.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FINE AND CLEAR ADVANCED HAND SANITIZER

ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70930-170
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL in 500 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Polysorbate 20 (UNII: 7T1F30V5YH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON (UNII: 24RS0A988O)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CITRAL (UNII: T7EU0O9VPP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70930-170-01	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/01/2020

Labeler - Natuzen Co.,Ltd. (688201272)

Registrant - Natuzen Co.,Ltd. (688201272)

Name	Address	ID/FEI	Business Operations
Establishment
Natuzen Co.,Ltd.		688201272	manufacture(70930-170)

Revised: 6/2020

Document Id: 031f77d3-1cd5-4fde-8e55-92da56e43484

Set id: 10e8a967-d559-4a18-91d3-dfba845a4871

Version: 1

Effective Time: 20200616