Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 2da8d2f0-30ce-420f-b8c7-a237e5d8d586
Route
TOPICAL
Published
Effective Date 2014-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
Water Carbomer Copolymer Type A Trolamine Edetate Disodium 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 2014-10-02

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

For external use only-hands

Flammable. Keep away from heat and flame

Keep out of eyes. In case of comtact with eyes, flush thoroughly with water

Avoid contact with broken skin

Indications and Usage

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Dosage and Administration

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants
Description

Active Ingredient Ethyl Alcohol 62%

Section 42229-5

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Section 50565-1

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50569-3

Do not inhale or ingest. Stop use and ask a doctor if skin irritation develops

Section 51727-6

Inactive Ingredient:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, 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

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 62%


Structured Label Content

Indications and Usage (34067-9)

Uses

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Dosage and Administration (34068-7)

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants
Warnings and Precautions (34071-1)

For external use only-hands

Flammable. Keep away from heat and flame

Keep out of eyes. In case of comtact with eyes, flush thoroughly with water

Avoid contact with broken skin

Section 42229-5 (42229-5)

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Section 50569-3 (50569-3)

Do not inhale or ingest. Stop use and ask a doctor if skin irritation develops

Section 51727-6 (51727-6)

Inactive Ingredient:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, 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)

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 62%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)