SPL v2
SPL
SPL Set ID 26c70482-499e-43e7-bf85-e4112e8b1bad
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 handwashing to decrease bacteria on the skin after assisting ill persons, before contact with a person under medical care or treatment, or after changing diapers, and to remove light soil and germs from the skin. 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 – Package Label

ANTISEPTIC HAND WIPES

Kills Over WON'T

99.99% DRY

of Harmful HANDS

Germs & WITH

Bacteria REPEATED

FRAGRANCE FREE USE

80 PRE-MOISTENED WIPES (6 in. x 7 in.)

Directions:

Snap open lid. Remove wipes for use. Wipe hands and wrists thoroughly, using more than one wipe if necessary. Snap lid closed between uses to preserve moisture and freshness of the product. When pack is empty dispose of the empty packaging materials properly or recycle with other plastic items. 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 handwashing to decrease bacteria on the skin after assisting ill persons, before contact with a person under medical care or treatment, or after changing diapers, and to remove light soil and germs from the skin. 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 – Package Label

ANTISEPTIC HAND WIPES

Kills Over WON'T

99.99% DRY

of Harmful HANDS

Germs & WITH

Bacteria REPEATED

FRAGRANCE FREE USE

80 PRE-MOISTENED WIPES (6 in. x 7 in.)

Purpose

Antiseptic

Directions:

Snap open lid. Remove wipes for use. Wipe hands and wrists thoroughly, using more than one wipe if necessary. Snap lid closed between uses to preserve moisture and freshness of the product. When pack is empty dispose of the empty packaging materials properly or recycle with other plastic items. 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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