Isopropyl Alcohol: Package Insert and Label Information

ISOPROPYL ALCOHOL- isopropyl alcohol spray
Angel Tree Products Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

For hand sanitizing to decrease bacteria on skin when water and soap 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.

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

purified water USP

Package Label — Principal Display Panel

118 ml NDC: 77890-002-02

Drug Label
(click image for full-size original)
ISOPROPYL ALCOHOL
alcohol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77890-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77890-002-02 118 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 10/07/2020
Labeler — Angel Tree Products Inc. (117523201)
Establishment
Name Address ID/FEI Operations
Angel Tree Products Inc. 117523201 manufacture (77890-002)

Revised: 10/2020 Angel Tree Products Inc.

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