drug facts

drug facts
SPL v1
SPL
SPL Set ID 151c6351-5fa7-4717-a494-9255a88ef7b0
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 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-09-01

Purpose

Antiseptic

Description

Alcohol 62%


Medication Information

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

Purpose

Antiseptic

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

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, FDC Yellow 5

Description

Alcohol 62%

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Package Label

Active Ingredient

Alcohol 62%

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

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

Purpose

Antiseptic

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

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, FDC Yellow 5

Use

■ For handwashing to decrease bacteria on the skin

■ Recommended for repeated use

Package Label

Active Ingredient

Alcohol 62%

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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