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

Purpose

ANTISEPTIC

Description

Benzalkonium Chloride 0.1%


Medication Information

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.

Uses

Health care personnel wipes to help reduce bacteria.

Purpose

ANTISEPTIC

Directions

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

■ Discard wipe in trash receptacle after use

■ Do not flush

Inactive Ingredients

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

Description

Benzalkonium Chloride 0.1%

Active Ingredient

Benzalkonium Chloride 0.1%

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

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.

Uses

Health care personnel wipes to help reduce bacteria.

Purpose (PURPOSE)

ANTISEPTIC

Directions

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

■ Discard wipe in trash receptacle after use

■ Do not flush

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.1%

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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