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NDC 72257-0250-01 FRESH HAND ANTISEPTIC CLEANER 60 mL/100mL Details

FRESH HAND ANTISEPTIC CLEANER 60 mL/100mL

FRESH HAND ANTISEPTIC CLEANER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by PROVINCE APOTHECARY INC. The primary component is ALCOHOL.

Product Information

NDC	72257-0250
Product ID	72257-250_d62d3e15-7689-798a-e053-2a95a90a5abc
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	FRESH HAND ANTISEPTIC CLEANER
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	60
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	PROVINCE APOTHECARY INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72257-0250-01 (72257025001)

Pricing Information	N/A
NDC Package Code	72257-250-01
Billing NDC	72257025001
Package	1 BOTTLE, PLASTIC in 1 BOX (72257-250-01) / 250 mL in 1 BOTTLE, PLASTIC (72257-250-00)
Marketing Start Date	2020-05-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a6bcdb52-cc75-f4b2-e053-2a95a90a5890 Details

DRUG FACTS

ACTIVE INGREDIENT

Ethyl Alcohol 60%

PURPOSE

Antiseptic

USES

Hand sanitizer to help reduce bacteria that potentially can cause disease.

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 keep out of 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 right away.

When using this product

Do not get into eyes.

Stop use and ask a doctor if

condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

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

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.

OTHER INFORMATION

■ Store between 15-30C (59-86F)

■ Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENTS

Water (Aqua), Aloe Barbadensis Leaf Juice*, Glycerin, Eucalyptus Globulus Oil*, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, FD&C Blue 1.

*Certified organic

QUESTIONS OR COMMENTS?

1-647-479-5525 or visit www.provinceapothecary.com

FRESH GEL HAND ANTISEPTIC CLEANER 250 mL (NDC 72257-250-00)

INGREDIENTS AND APPEARANCE

FRESH HAND ANTISEPTIC CLEANER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72257-250
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
LAURETH-7 (UNII: Z95S6G8201)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72257-250-01	1 in 1 BOX	05/28/2020
1	NDC:72257-250-00	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/28/2020

Labeler - PROVINCE APOTHECARY INC (201115232)

Registrant - PROVINCE APOTHECARY INC (201115232)

Revised: 1/2022

Document Id: d62d3e15-7689-798a-e053-2a95a90a5abc

Set id: a6bcdb52-cc75-f4b2-e053-2a95a90a5890

Version: 2

Effective Time: 20220101