SPL v2
SPL
SPL Set ID fc2be018-6110-4828-9bd8-25ac2f85e378
Route
TOPICAL
Published
Effective Date 2012-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (.62 mL)
Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-02-15

Description

DRUG FACTS

Purpose

Antiseptic


Medication Information

Warnings and Precautions

For external use only.

Purpose

Antiseptic

Description

DRUG FACTS

Uses:

For cleansing of exposed areas of the body to decrease bacteria on the skin after assisting ill persons or after athletic competition involving direct skin contact, or swimming / bathing in water that has not been pre-treated for bacterial contamination, or any other activity where exposure of the skin to germs may be of concern. Not for use on intimate parts of the body, as the alcohol may sting or cause inflammation.

Section 42229-5

DRUG FACTS

Section 50570-1
  • Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
  • Not for use on broken or irritated skin, unless recommended by a health care professional for wound or first aid cleansing.
  • Discontinue use and seek medical attention if skin irritation or redness develops.
Section 51945-4

Principal Display Panel – Case Label

A I C AMERICAN INFECTION CONTROL™

ANTISEPTIC BODY WIPES

65 wipes per canister / 12 units per case

Made in Turkey for:

American Infection Control, Inc.

23950 Commerce Park

Beachwood, Ohio 44122

(216) 342-4660

Directions:

Remove lid and seal. Open cap. Thread center towelette through lid. Pull up straight to remove towelette. Wipe hands and wrists thoroughly. Close cap and dispose towelette appropriately. After first use continue to dispense towelettes until canister is empty.

FLAMMABLE. KEEP AWAY FROM HIGH HEAT OR DIRECT FLAME

Active Ingredient

Ethyl Alcohol 62% (v/v)

Inactive Ingredients:

Aloe Barbadensis Extract, Propylene Glycol, Purified Water.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a poison control center immediately.


Structured Label Content

Uses:

For cleansing of exposed areas of the body to decrease bacteria on the skin after assisting ill persons or after athletic competition involving direct skin contact, or swimming / bathing in water that has not been pre-treated for bacterial contamination, or any other activity where exposure of the skin to germs may be of concern. Not for use on intimate parts of the body, as the alcohol may sting or cause inflammation.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)
  • Do not use in eyes. In case of eye contact, immediately flush with water and seek medical advice.
  • Not for use on broken or irritated skin, unless recommended by a health care professional for wound or first aid cleansing.
  • Discontinue use and seek medical attention if skin irritation or redness develops.
Section 51945-4 (51945-4)

Principal Display Panel – Case Label

A I C AMERICAN INFECTION CONTROL™

ANTISEPTIC BODY WIPES

65 wipes per canister / 12 units per case

Made in Turkey for:

American Infection Control, Inc.

23950 Commerce Park

Beachwood, Ohio 44122

(216) 342-4660

Purpose

Antiseptic

Directions:

Remove lid and seal. Open cap. Thread center towelette through lid. Pull up straight to remove towelette. Wipe hands and wrists thoroughly. Close cap and dispose towelette appropriately. After first use continue to dispense towelettes until canister is empty.

FLAMMABLE. KEEP AWAY FROM HIGH HEAT OR DIRECT FLAME

Active Ingredient

Ethyl Alcohol 62% (v/v)

Inactive Ingredients:

Aloe Barbadensis Extract, Propylene Glycol, Purified Water.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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