Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID d03d7cea-3dd7-4a27-9ae3-9622ddac087d
Route
TOPICAL
Published
Effective Date 2013-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzethonium (0.13 g)
Inactive Ingredients
Water Carbomer Copolymer Type A Trolamine Polyoxyl 40 Hydrogenated Castor Oil D&c Red No. 33 Fd&c Blue No. 1 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-04-12

Description

Active Ingredient Benzethonium Chloride 0.13%


Medication Information

Warnings and Precautions

For external use only

When using this product: Keep out of eyes.  Do not ingest.



Indications and Usage

Uses

To decrease bacteria on the skin

Dosage and Administration

Directions

  • Rub a dime size drop into hands

Description

Active Ingredient Benzethonium Chloride 0.13%

Section 44425-7

Other Information:

  • Do not store above 105F
  • May discolor some fabrics
Section 50565-1

Keep out of reach of children. If swallowed, get medical assistance.

Section 50569-3

Stop use and ask a doctor if skin irritation develops

Section 51727-6

Inactive Ingredient:

Deionized Water, Carbomer, Triehtanolamine, PEG-40 Hydrogenated Castor Oil, Fragrance, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

Section 51945-4

lab

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Benzethonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Uses

To decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions

  • Rub a dime size drop into hands

Warnings and Precautions (34071-1)

For external use only

When using this product: Keep out of eyes.  Do not ingest.



Section 44425-7 (44425-7)

Other Information:

  • Do not store above 105F
  • May discolor some fabrics
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical assistance.

Section 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation develops

Section 51727-6 (51727-6)

Inactive Ingredient:

Deionized Water, Carbomer, Triehtanolamine, PEG-40 Hydrogenated Castor Oil, Fragrance, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

Section 51945-4 (51945-4)

lab

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Benzethonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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