drug facts

drug facts
SPL v1
SPL
SPL Set ID 71ebcb68-2b86-1afd-e053-2a95a90a0d45
Route
topical
Published
Effective Date 2018-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (62 g)
Inactive Ingredients
water glycerin polyoxyl 40 hydrogenated castor oil propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-07-20

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

Uses

■ Spray on hands to decrease bacteria

■ Recommended for repeated use

Purpose

Antiseptic

Directions

■ Spray on hands and rub together 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 105ºF ■ May discolor some fabrics

Inactive Ingredients

Water, PEG-40 Hydrogenated Castor Oil, Glycerin, Propylene Glycol, Fragrance

Description

Alcohol 62%

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, get medical help or Poison Control Center right away.


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

Uses

■ Spray on hands to decrease bacteria

■ Recommended for repeated use

Purpose

Antiseptic

Directions

■ Spray on hands and rub together 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 105ºF ■ May discolor some fabrics

Inactive Ingredients

Water, PEG-40 Hydrogenated Castor Oil, Glycerin, Propylene Glycol, Fragrance

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, get medical help or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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