SPL v1
SPL
SPL Set ID 4e4825d2-aff2-4732-a3bf-0239884a9476
Route
TOPICAL
Published
Effective Date 2014-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 mg)
Inactive Ingredients
Water Cocamidopropyl Betaine Cetrimonium Chloride Cocamidopropylamine Oxide Didecyldimonium Chloride Methylparaben Propylparaben Propylene Glycol Diazolidinyl Urea Allantoin Trolamine Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-05-23

Description

Benzalkonium Chloride, 0.13%


Medication Information

Warnings and Precautions

For external use only.

Do not use in the eyes or apply over large areas of the baody.  Stop use and consult a doctor if rash or irritation develops or lasts.

Indications and Usage

Use for hand sanitizing to decrease bacteria on the skin.

Dosage and Administration

Directions. Apply to one palm and rub hands together.  Distribute over hands and fingers until dry.

You may report a serious adverse reaction to 1-800-356-9522, 8am - 5pm CST.  www.muellersportsmedicine.com

Description

Benzalkonium Chloride, 0.13%

Section 50565-1

Keep out of reach if children.  If swallowed, get medical help or contact a Poison Center right away.

Section 51727-6

Water, Didecyldimonium Chloride , Fragrance, Methylparaben, Propylparaben, Propylene Glycol, Diazolidinyl Urea, Allantoin, Cocamidopropylamine Oxide, Cetrimonium Chloride, Cocamidopropyl Betaine, Green 5, Violet 2, Triethanolamine, Citric Acid.

Section 51945-4

Section 55105-1

Antiseptic Hand Sanitizer

Section 55106-9

Benzalkonium Chloride, 0.13%


Structured Label Content

Indications and Usage (34067-9)

Use for hand sanitizing to decrease bacteria on the skin.

Dosage and Administration (34068-7)

Directions. Apply to one palm and rub hands together.  Distribute over hands and fingers until dry.

You may report a serious adverse reaction to 1-800-356-9522, 8am - 5pm CST.  www.muellersportsmedicine.com

Warnings and Precautions (34071-1)

For external use only.

Do not use in the eyes or apply over large areas of the baody.  Stop use and consult a doctor if rash or irritation develops or lasts.

Section 50565-1 (50565-1)

Keep out of reach if children.  If swallowed, get medical help or contact a Poison Center right away.

Section 51727-6 (51727-6)

Water, Didecyldimonium Chloride , Fragrance, Methylparaben, Propylparaben, Propylene Glycol, Diazolidinyl Urea, Allantoin, Cocamidopropylamine Oxide, Cetrimonium Chloride, Cocamidopropyl Betaine, Green 5, Violet 2, Triethanolamine, Citric Acid.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic Hand Sanitizer

Section 55106-9 (55106-9)

Benzalkonium Chloride, 0.13%


Advanced Ingredient Data


Raw Label Data

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