SPL v2
SPL
SPL Set ID 84dfd3da-3749-4ac5-aa28-e26c9b99bcb7
Route
TOPICAL
Published
Effective Date 2020-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Aloe Vera Leaf Maltodextrin Glycerin Propylene Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-14

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

For external use only. Do not drink.

Flammable. Keep away from fire or flame

Avoid contact with broken skin

Directions
  • Apply the sanitizer to the palm of one hand and rub all over hands until your hands are dry
  • Children under 6 years of age should be supervised when using
Active Ingredient

Ethyl Alcohol 75%

Other Information
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, Tocopheryl Acetate.

Principal Display Panel

NDC 75629-750-08

annie®​

MOISTURIZING HAND SANITIZER GEL WITH VITAMIN E

75% Alcohol

Kills 99.9% of Most Germs

8 FL OZ (236mL)

NDC 75629-750-17

annie®

MOISTURIZING HAND SANITIZER GEL WITH VITAMIN E

75% Alcohol

Kills 99.9% of Most Germs

16.9 FL OZ (500mL)

NDC 75629-750-01

annie®

MOISTURIZING HAND SANITIZER GEL WITH VITAMIN E

75% Alcohol

Kills 99.9% of Most Germs

1 GALLON (128 FL OZ)

When Using This Product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use and Ask A Doctor If

irritation or rash appears and lasts

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Not recommended for infants


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin

Purpose

Antiseptic

Warnings

For external use only. Do not drink.

Flammable. Keep away from fire or flame

Avoid contact with broken skin

Directions
  • Apply the sanitizer to the palm of one hand and rub all over hands until your hands are dry
  • Children under 6 years of age should be supervised when using
Active Ingredient

Ethyl Alcohol 75%

Other Information (Other information)
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Aloe Barbadensis Leaf Juice, Maltodextrin, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Fragrance, Tocopheryl Acetate.

Principal Display Panel

NDC 75629-750-08

annie®​

MOISTURIZING HAND SANITIZER GEL WITH VITAMIN E

75% Alcohol

Kills 99.9% of Most Germs

8 FL OZ (236mL)

NDC 75629-750-17

annie®

MOISTURIZING HAND SANITIZER GEL WITH VITAMIN E

75% Alcohol

Kills 99.9% of Most Germs

16.9 FL OZ (500mL)

NDC 75629-750-01

annie®

MOISTURIZING HAND SANITIZER GEL WITH VITAMIN E

75% Alcohol

Kills 99.9% of Most Germs

1 GALLON (128 FL OZ)

When Using This Product (When using this product)

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

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

irritation or rash appears and lasts

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

If swallowed, get medical help or contact a Poison Control Center right away.

Not recommended for infants


Advanced Ingredient Data


Raw Label Data

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