2bd271ff-bb2e-426b-a7ad-87bb7dfb3df6

SPL v1
SPL
SPL Set ID 2bd271ff-bb2e-426b-a7ad-87bb7dfb3df6
Route
topical
Published
Effective Date 2024-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (70 mL)
Inactive Ingredients
nitrogen sodium benzoate water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-19

Purpose

First aid antiseptic

Description

Isopropyl alcohol 70% by volume


Medication Information

Warnings

For external use only.  Flammable,keep away from heat, spark, electrical, fire or flame 

  • will produce serious gastric disturbances if taken internally
Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • helps relieve minor muscular aches due to exertion
Purpose

First aid antiseptic

Directions
  • clean the affected area 
  • apply a small amount of product on the affected area 1 to 3 times a day 
  • may be covered with a sterile bandage 
  • if bandaged, let dry first
Other Information
  • keep tightly closed and at controlled room temperature 
  • does not contain, nor is it intended as a substitute for grain or ethyl alcohol
Inactive Ingredients

Nitrogen, Purified Water, Sodium Benzoate

Description

Isopropyl alcohol 70% by volume

Do Not Use
  • in the eyes or apply over large areas of the body 
  • longer than 1 week 
  • do not inhale
Active Ingredient

Isopropyl alcohol 70% by volume

Package Labeling:

Stop Use and Ask A Doctor If
  • the condition persists or gets worse 
  • irritation, pain, or redness persists or worsens 
  • swelling, rash, or fever develops
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites or serious burns.


Structured Label Content

Warnings

For external use only.  Flammable,keep away from heat, spark, electrical, fire or flame 

  • will produce serious gastric disturbances if taken internally
Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • helps relieve minor muscular aches due to exertion
Purpose

First aid antiseptic

Directions
  • clean the affected area 
  • apply a small amount of product on the affected area 1 to 3 times a day 
  • may be covered with a sterile bandage 
  • if bandaged, let dry first
Other Information (Other information)
  • keep tightly closed and at controlled room temperature 
  • does not contain, nor is it intended as a substitute for grain or ethyl alcohol
Inactive Ingredients (Inactive ingredients)

Nitrogen, Purified Water, Sodium Benzoate

Do Not Use (Do not use)
  • in the eyes or apply over large areas of the body 
  • longer than 1 week 
  • do not inhale
Active Ingredient (Active ingredient)

Isopropyl alcohol 70% by volume

Package Labeling:

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse 
  • irritation, pain, or redness persists or worsens 
  • swelling, rash, or fever develops
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds, animal bites or serious burns.


Advanced Ingredient Data


Raw Label Data

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