Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 270a5976-5ab0-4b95-afdd-ac93598ca193
Route
TOPICAL
Published
Effective Date 2013-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Trolamine Tocopherol Jojoba Oil Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-09-01

Description

Alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 62%

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Warnings

■ For external use only

■ Flammable, keep away from fire and flame

■ Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

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

Package Label

Active Ingredient

Alcohol 62%

Other Information

■ Store below 105F ■ May discolor some fabrics

Inactive Ingredients

Water, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Carbomer, Fragrance, Tocopherol,  Simmondsia Chinensis (Jooba) Seed Oil, Benzophenone-4, FDC Blue 1, DC Red 33

When Using This Product

■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop Use and Ask A Doctor If

■ Condition worsens ■ Redness or irritation develops

■ If condition persists for more than 3 days

Keep Out of Reach of Children

If swallowed contact a doctor or Poison Control Center immediately.


Structured Label Content

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Purpose

Antiseptic

Warnings

■ For external use only

■ Flammable, keep away from fire and flame

■ Does not contain grain alcohol; do not drink, if taken internally will produce serious gastric disturbances

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

Package Label

Active Ingredient

Alcohol 62%

Other Information (Other information)

■ Store below 105F ■ May discolor some fabrics

Inactive Ingredients

Water, Glycerin, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Carbomer, Fragrance, Tocopherol,  Simmondsia Chinensis (Jooba) Seed Oil, Benzophenone-4, FDC Blue 1, DC Red 33

When Using This Product (When using this product)

■ Avoid the eyes and mucous membranes ■ In the case of eyes or mucous membrane contact; rinse area thoroughly with water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ Condition worsens ■ Redness or irritation develops

■ If condition persists for more than 3 days

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed contact a doctor or Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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