Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fca90a2a-3f56-4c47-80d9-054867a8fa50
Route
TOPICAL
Published
Effective Date 2020-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 1)
Inactive Ingredients
Water Cetylpyridinium Chloride Hydroxyacetophenone Citric Acid Monohydrate Aloe Vera Leaf Butylene Glycol 1,2-hexanediol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-01

Description

Benzalkonium Chloride 0.1%

Purpose

ANTISEPTIC


Medication Information

Purpose

ANTISEPTIC

Description

Benzalkonium Chloride 0.1%

Uses

Health care personnel wipes to help reduce bacteria.

Warnings

For external use only. Keep away from heat or flame

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Do not use

• in children less than 2 months of age

• on open skin wounds

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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Discard wipe in trash receptacle after use

■ Do not flush

Active Ingredient

Benzalkonium Chloride 0.1%

Inactive Ingredients

Water, Cetylpyridinium Chloride, Hydroxyacetophenone, Citric Acid, Aloe Barbadensis Leaf Extract, Butylene Glycol, 1,2-Hexanediol, Tocopheryl Acetate

Keep Out of Reach of Children

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

Package Label: Meditime Sanitizing Wipes (20sheets)

Package Label: Meditime Sanitizing Wipes (70sheets)


Structured Label Content

Uses

Health care personnel wipes to help reduce bacteria.

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

For external use only. Keep away from heat or flame

--------------------------------------------------------------------------------------------------------

Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Discard wipe in trash receptacle after use

■ Do not flush

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.1%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Cetylpyridinium Chloride, Hydroxyacetophenone, Citric Acid, Aloe Barbadensis Leaf Extract, Butylene Glycol, 1,2-Hexanediol, Tocopheryl Acetate

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.

Package Label: Meditime Sanitizing Wipes (20sheets)

Package Label: Meditime Sanitizing Wipes (70sheets)


Advanced Ingredient Data


Raw Label Data

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