Tricstlfrtresspnklhndsntzralch62

Tricstlfrtresspnklhndsntzralch62
SPL v1
SPL
SPL Set ID abfb3a46-7fe3-915d-e053-2a95a90aeec2
Route
TOPICAL
Published
Effective Date 2020-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 mL)
Inactive Ingredients
D&c Red No. 33 Polyoxyl 40 Hydrogenated Castor Oil Water Trolamine Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-30

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 open flame and sources of heat

■ Does not contain grain alcohol; do not drink. If taken internally will produce gastric distrubances.

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.

Questions?

■ 1-800-278-9218

Package Label

Active Ingredient

Alcohol 62%

Other Information

■ Store below 105ºF

■ May discolor some fabrics.

Inactive Ingredients

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, PEG-40 Hydrogenated Castor Oil, D&C RED N0.33, FD&C YELLOW NO.5

When Using This Product

■ Avoid the eyes and mucoous membranes

■ In the case of eyes or mucous membranes contacr, rinse area thoroughly with water

Stop Use and Ask A Doctor If

■ Condition worsens

■ Redness or irritation develops

■ 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 open flame and sources of heat

■ Does not contain grain alcohol; do not drink. If taken internally will produce gastric distrubances.

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.

Questions?

■ 1-800-278-9218

Package Label

Active Ingredient (Active ingredient)

Alcohol 62%

Other Information (Other information)

■ Store below 105ºF

■ May discolor some fabrics.

Inactive Ingredients (Inactive ingredients)

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, PEG-40 Hydrogenated Castor Oil, D&C RED N0.33, FD&C YELLOW NO.5

When Using This Product (When using this product)

■ Avoid the eyes and mucoous membranes

■ In the case of eyes or mucous membranes contacr, 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

■ 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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