SPL v1
SPL
SPL Set ID c62ea9b8-bdcd-49a3-87ed-27a95a8e517e
Route
TOPICAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 mL)
Inactive Ingredients
Water Methyl Salicylate Laneth-75 Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-30

Description

FIRST AID AND ANTISEPTIC: Helps prevent the risk of infection in minor cuts, scrapes and burns WARNING :Flammable,keep away from heat ,spark ,electrical fire or flame : Use only in well ventilated area .Fumes may be harmful CAUTION : Do not point at self or others, product will squirt when squeezed

Purpose

First Aid Antiseptic


Medication Information

Purpose

First Aid Antiseptic

Description

FIRST AID AND ANTISEPTIC: Helps prevent the risk of infection in minor cuts, scrapes and burns WARNING :Flammable,keep away from heat ,spark ,electrical fire or flame : Use only in well ventilated area .Fumes may be harmful CAUTION : Do not point at self or others, product will squirt when squeezed

Uses

First aid to help prevent the risk of infection in

  • Minor cuts
  • Scrapes
  • Burns
Section 50565-1

Warnings

For external use only

  • If taken internally serious gastric disturbances will result.

Flammable : keep away from fire or flame ,heat, spark ,electrical.

Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.

When using this product : do not get into eyes ,do not inhale ,do not apply over large area of the body ,do not use longer than 1 week.

Stop use and ask a doctor if condition persist or get worse.

Keep out of reach of children

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

Caution

  • Fumes can be acutely irritating to skin ,eyes and the respiratory system.
  • Do not apply to irritated skin or if excessive irritation develops.
  • Avoid getting into eyes or mucus membranes .Avoid inhaling this product.
Directions
  • Clean the affected area.
  • Apply a small amount of this product on the area 1 to 2 times daily.
  • May be covered with a sterile bandage.
  • If bandaged lets dry first.
Product Image

Other Information
  • Does not contain ,nor is intended as a substitute for grain or ethyl alcohol.
  • Tamper Evident : Do not use if the under cap safety foil is broken or missing.
Active Ingredients

Isopropyl Alcohol 70%

Inactive Ingredients
  • Water ( Aqua)
  • Methyl Salicylate
  • Laneth -75
  • FD and C Blue #1
  • FD AND C YELLOW #5
Extra Information On Front Label :
  • FIRST AID AND ANTISEPTIC: Helps prevent the risk of infection in minor cuts, scrapes and burns
  • WARNING :Flammable,keep away from heat ,spark ,electrical fire or flame : Use only in well ventilated area .Fumes may be harmful
  • CAUTION : Do not point at self or others, product will squirt when squeezed

Structured Label Content

Uses

First aid to help prevent the risk of infection in

  • Minor cuts
  • Scrapes
  • Burns
Section 50565-1 (50565-1)

Purpose

First Aid Antiseptic

Warnings

For external use only

  • If taken internally serious gastric disturbances will result.

Flammable : keep away from fire or flame ,heat, spark ,electrical.

Ask a doctor before use for deep or puncture wounds, animal bites or serious burns.

When using this product : do not get into eyes ,do not inhale ,do not apply over large area of the body ,do not use longer than 1 week.

Stop use and ask a doctor if condition persist or get worse.

Keep out of reach of children

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

Caution

  • Fumes can be acutely irritating to skin ,eyes and the respiratory system.
  • Do not apply to irritated skin or if excessive irritation develops.
  • Avoid getting into eyes or mucus membranes .Avoid inhaling this product.
Directions
  • Clean the affected area.
  • Apply a small amount of this product on the area 1 to 2 times daily.
  • May be covered with a sterile bandage.
  • If bandaged lets dry first.
Product Image

Other Information
  • Does not contain ,nor is intended as a substitute for grain or ethyl alcohol.
  • Tamper Evident : Do not use if the under cap safety foil is broken or missing.
Active Ingredients

Isopropyl Alcohol 70%

Inactive Ingredients (Inactive ingredients)
  • Water ( Aqua)
  • Methyl Salicylate
  • Laneth -75
  • FD and C Blue #1
  • FD AND C YELLOW #5
Extra Information On Front Label : (EXTRA INFORMATION ON FRONT LABEL :)
  • FIRST AID AND ANTISEPTIC: Helps prevent the risk of infection in minor cuts, scrapes and burns
  • WARNING :Flammable,keep away from heat ,spark ,electrical fire or flame : Use only in well ventilated area .Fumes may be harmful
  • CAUTION : Do not point at self or others, product will squirt when squeezed

Advanced Ingredient Data


Raw Label Data

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