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

Description

Isopropyl alcohol 70% by volume

Purpose

First aid antiseptic


Medication Information

Purpose

First aid antiseptic

Description

Isopropyl alcohol 70% by volume

Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • helps relieve minor muscular aches due to exertion
Warnings

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

  • will produce serious gastric disturbances if taken internally
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
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

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
Package Labeling:

Inactive Ingredients

Nitrogen, Purified Water, Sodium Benzoate

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

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

Warnings

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

  • will produce serious gastric disturbances if taken internally
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
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

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
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Nitrogen, Purified Water, Sodium Benzoate

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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