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NDC 72204-0003-04 PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER 63 mL/100mL Details

PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER 63 mL/100mL

PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Iontera, Inc. The primary component is ALCOHOL.

Product Information

NDC	72204-0003
Product ID	72204-003_ebe3f3fb-6a95-645d-e053-2995a90aaa99
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	PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	63
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Iontera, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	n/a

Package

Package Images

NDC 72204-0003-04 (72204000304)

Pricing Information	N/A
NDC Package Code	72204-003-04
Billing NDC	72204000304
Package	30 PACKET in 1 BOX (72204-003-04) / 3 mL in 1 PACKET
Marketing Start Date	2020-04-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a3d3dacd-21bd-1109-e053-2995a90a0c7e Details

Drug Facts

Active ingredient

Alcohol 63% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

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, Butylene Glycol, Glycerin, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Hydrolyzed Collagen, Carbomer, 1,2-Hexanediol, Ethylhexylglycerin, Triethanolamine, Phenoxyethanol, Fragrance

Product Packaging - 50 mL

preventMD

EXTRACLEAN

hydrating

hand sanitizer

contains 63% alcohol

50 mL 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

PREVENTMD EXTRACLEAN HYDRATING HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72204-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72204-003-01	50 mL in 1 POUCH; Type 0: Not a Combination Product	04/22/2020
2	NDC:72204-003-02	23 mL in 1 POUCH; Type 0: Not a Combination Product	04/22/2020
3	NDC:72204-003-03	50 in 1 BOX	04/22/2020
3		3.5 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC:72204-003-04	30 in 1 BOX	04/22/2020
4		3 mL in 1 PACKET; 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	04/22/2020	05/31/2023

Labeler - Iontera, Inc (004818058)

Revised: 10/2022

Document Id: ebe3f3fb-6a95-645d-e053-2995a90aaa99

Set id: a3d3dacd-21bd-1109-e053-2995a90a0c7e

Version: 2

Effective Time: 20221025