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NDC 35418-0402-12 Isopropyl Alcohol 70 mL/100mL Details

Isopropyl Alcohol 70 mL/100mL

Isopropyl Alcohol is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Zee Medical. The primary component is ALCOHOL.

Product Information

NDC	35418-0402
Product ID	35418-402_6016d1da-5c76-7acc-e053-2a91aa0a3e57
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	Isopropyl Alcohol
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Zee Medical
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 35418-0402-12 (35418040212)

Pricing Information	N/A
NDC Package Code	35418-402-12
Billing NDC	35418040212
Package	118 mL in 1 BOTTLE, SPRAY (35418-402-12)
Marketing Start Date	2010-07-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8dc593e3-1163-4978-a39c-a9b29074699a Details

Active ingredient

Isopropyl alcohol 70%

Purpose

First aid antiseptic

Uses

first aid to help prevent infection in minor

cuts
scrapes
burns

Warnings

For external use only

Flammable

Caution: FLAMMABLE. Keep away from fire, flame or heat

Do not use

in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor

Ask a doctor before use if you have a

deep wound
puncture wound
animal bite
serious burns

Stop use and ask a doctor if

the condition persists or gets worse

Keep out of the reach of children

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

Directions

clean the affected area
spray a small amount of this product in the area 1 to 3 times daily
may be covered with a sterile bandage. If bandaged, let dry first

Other information

store at room temperature
this product is not made from ethyl or grain alcohol and it is not intended as a substitute

Inactive ingredient

purified water

Questions?

1-800-841-8417 or zeemedical.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

ISOPROPYL ALCOHOL

alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35418-402
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:35418-402-10	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/08/2010
2	NDC:35418-402-12	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/08/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/08/2010

Labeler - Zee Medical (009645623)

Registrant - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(35418-402)

Revised: 12/2017

Document Id: 6016d1da-5c76-7acc-e053-2a91aa0a3e57

Set id: 8dc593e3-1163-4978-a39c-a9b29074699a

Version: 7

Effective Time: 20171211