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NDC 67385-0025-04 clean n natural Hand Sanitizer 700 mg/mL Details

clean n natural Hand Sanitizer 700 mg/mL

clean n natural Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Garcoa, Inc.. The primary component is ALCOHOL.

Product Information

NDC	67385-0025
Product ID	67385-025_a149315a-89b8-4c2e-abe7-1cd0a7b186f5
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	clean n natural Hand Sanitizer
Proprietary Name Suffix	Antimicrobial
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	700
Active Ingredient Units	mg/mL
Substance Name	ALCOHOL
Labeler Name	Garcoa, Inc.
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 67385-0025-04 (67385002504)

Pricing Information	N/A
NDC Package Code	67385-025-04
Billing NDC	67385002504
Package	3785 mL in 1 BOTTLE, PUMP (67385-025-04)
Marketing Start Date	2021-01-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1fdd5356-3121-4849-be82-fc9c997edc57 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses

⬥: Hand sanitizer to help reduce bacteria on the skin that could cause disease
⬥: Recommended for repeated use

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

Directions

⬥: place enough product in your palm to thoroughly cover your hands
⬥: Rub hands together briskly until dry.
⬥: Children under 6 years of age should be supervised when using this product.

Other information

⬥: Store at room temperature
⬥: May discolor certain fabrics or surfaces.

Inactive ingredients

AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Citrus Limon (Lemon) Peel Oil, Fragrance, Glycerin, Isopropyl Myristate, PEG-6, Propylene Glycol, Tocopheryl Acetate, Water

Questions or comments?

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PRINCIPAL DISPLAY PANEL - 3 Bottle Carton

3 PACK

(FULL SIZE 12 FL OZ)

clean n' natural®

HAND

SANITIZER

ALCOHOL

70%

BASED

Helps reduce pathogenic

germs on hands

With moisturizers and vitamin E

Contains: 3 Pump Closure 12 FL. OZ. / 354 mL Bottles • Total: 36 FL. OZ. / 1062 mL

PRINCIPAL DISPLAY PANEL - 3 Bottle Carton

INGREDIENTS AND APPEARANCE

CLEAN N NATURAL HAND SANITIZER ANTIMICROBIAL

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67385-025
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
Propylene Glycol (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67385-025-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
2	NDC:67385-025-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
3	NDC:67385-025-13	3 in 1 CARTON	06/30/2020
3	NDC:67385-025-03	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:67385-025-04	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/08/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	06/30/2020

Labeler - Garcoa, Inc. (036464697)

Name	Address	ID/FEI	Business Operations
Establishment
Sigan America, LLC		964976968	MANUFACTURE(67385-025)

Revised: 1/2022

Document Id: a149315a-89b8-4c2e-abe7-1cd0a7b186f5

Set id: 1fdd5356-3121-4849-be82-fc9c997edc57

Version: 3

Effective Time: 20220127