Bf,vivo, Rbs, Hand Sanitizer

Bf,vivo, Rbs, Hand Sanitizer
SPL v1
SPL
SPL Set ID a332169d-b73b-e25b-e053-2a95a90a60ea
Route
TOPICAL
Published
Effective Date 2020-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Glycerin Water Carbomer Interpolymer Type A (55000 Cps) Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-06

Description

Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 70%

Use

■ Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only. Flammable, keep away from fire and flame.

Directions

■ Apply a dime sized amount to hands. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to avoid swallowing

Do Not Use

■ on children less than 2 months of age ■ on open skin wounds

Package Label

Active Ingredient

Alcohol 70%

Other Information

Store between 59-86ºF. Avoid freezing and excessive heat above 104ºF

Inactive Ingredients

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Aloe Barbadensis Extract, Tocopheryl Acetate

When Using This Product

■ keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly wiyh water.

Stop Use and Ask A Doctor If

irritation and redness develops and persists.

Keep Out of Reach of Children

if swallowed, contact a doctor or Poison Control Center right away.


Structured Label Content

Use

■ Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Purpose

Antiseptic

Warnings

For external use only. Flammable, keep away from fire and flame.

Directions

■ Apply a dime sized amount to hands. Rub hands together until dry ■ Supervise children under 6 years of age when using this product to avoid swallowing

Do Not Use (Do not use)

■ on children less than 2 months of age ■ on open skin wounds

Package Label

Active Ingredient

Alcohol 70%

Other Information (Other information)

Store between 59-86ºF. Avoid freezing and excessive heat above 104ºF

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Triethanolamine, Aloe Barbadensis Extract, Tocopheryl Acetate

When Using This Product (When using this product)

■ keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly wiyh water.

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

irritation and redness develops and persists.

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

if swallowed, contact a doctor or Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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