Drug Fact

Drug Fact
SPL v2
SPL
SPL Set ID 70217622-d858-4afd-b60d-00bf25f6d256
Route
TOPICAL
Published
Effective Date 2016-08-15
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 Glycerin D&c Red No. 33 Fd&c Blue No. 1 Fd&c Yellow No. 5 Propylene Glycol Peg-40 Castor Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-08-15

Description

Active Ingredient Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

For external use only-hands

Flammable. Keep away from heat and flame

Does not contain grain alcohol, do not drink. If taken internally will produce serious gastric disturbances

Indications and Usage

Uses

For hand washing to decrease bacteria on the skin

Dosage and Administration

Directions

  • Rub dime sized amount between hands until dry
  • Supervise children in the use of this product
  • In the case of eye contact, rinse eyes thoroughly with water
Description

Active Ingredient Ethyl Alcohol 62%

Section 42229-5

Other Information

Store below 105F

May discolor some fabrics

Section 50565-1

Keep out of reach of children.

If swallowed, contact a doctor or a Poison Control Center immediately.

Section 50569-3

When using this product

Avoid the eyes and mucous membranes

In case of eye or mucous membrane contact, rinse area thoroughly with water

Stop use and ask a doctor if

Condiiton worsens

Redness or irritation develops

If condition persists for more than three days

Section 51727-6

Inactive Ingredient:

Water, Glycerin, Propylene Glycol, FEG-40 Hydrogenated Castor Oil, Triethanolamine, Carbomer, tocopherol, Fragrance, D and C Red No. 33, FD and C Blue No. 1, FD and C Yellow No. 5,

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

For hand washing to decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions

  • Rub dime sized amount between hands until dry
  • Supervise children in the use of this product
  • In the case of eye contact, rinse eyes thoroughly with water
Warnings and Precautions (34071-1)

For external use only-hands

Flammable. Keep away from heat and flame

Does not contain grain alcohol, do not drink. If taken internally will produce serious gastric disturbances

Section 42229-5 (42229-5)

Other Information

Store below 105F

May discolor some fabrics

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, contact a doctor or a Poison Control Center immediately.

Section 50569-3 (50569-3)

When using this product

Avoid the eyes and mucous membranes

In case of eye or mucous membrane contact, rinse area thoroughly with water

Stop use and ask a doctor if

Condiiton worsens

Redness or irritation develops

If condition persists for more than three days

Section 51727-6 (51727-6)

Inactive Ingredient:

Water, Glycerin, Propylene Glycol, FEG-40 Hydrogenated Castor Oil, Triethanolamine, Carbomer, tocopherol, Fragrance, D and C Red No. 33, FD and C Blue No. 1, FD and C Yellow No. 5,

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)