SPL v1
SPL
SPL Set ID 0db00216-446e-45d0-a7e8-24b8ec409333
Route
TOPICAL
Published
Effective Date 2020-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Aloe Vera Leaf Glycerin Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-09

Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Use

Hand Sanitizer to help reduce bacteria on the skin

Storage
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Warnings

Flammable. Keep away from fire or flame. For external use only.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using ASPHICARE Hand sanitizer

Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information

Hand sanitizers provide a convenient alternative when hand washing with plain soap and water is unavailable. The Centers for Disease Control

and Prevention advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer. Hand sanitizers should not replace hand washing with soap and water. FDA conducts ongoing review of OTC antiseptic active ingredients to determine whether these ingredients are safe and effective for their intended uses.

Inactive Ingredients

Water (Aqua), Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Glycerin, Isosteareth-200 Linoleate, Fragrance Triethanolamine

Principal Display Panel

NDC 70735-070-01

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

1 FL OZ (30 mL)

NDC 70735-070-02

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

2 FL OZ (60 mL)

NDC 70735-070-03

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

3 FL OZ (89 mL)

NDC 70735-070-04

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

4 FL OZ (118 mL)

NDC 70735-070-06

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

6 FL OZ (177 mL)

NDC 70735-070-08

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

8 FL OZ (236 mL)

NDC 70735-070-16

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

16 FL OZ (473 mL)

NDC 70735-070-32

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

32 FL OZ (946 mL)

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 or lasts

Keep Out of Reach of Children.

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


Structured Label Content

Use

Hand Sanitizer to help reduce bacteria on the skin

Purpose

Antiseptic

Storage
  • Store below 110°F (43°C)
  • May discolor certain fabrics or surfaces
Warnings

Flammable. Keep away from fire or flame. For external use only.

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using ASPHICARE Hand sanitizer

Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information

Hand sanitizers provide a convenient alternative when hand washing with plain soap and water is unavailable. The Centers for Disease Control

and Prevention advises that washing hands with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based hand sanitizer. Hand sanitizers should not replace hand washing with soap and water. FDA conducts ongoing review of OTC antiseptic active ingredients to determine whether these ingredients are safe and effective for their intended uses.

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Glycerin, Isosteareth-200 Linoleate, Fragrance Triethanolamine

Principal Display Panel

NDC 70735-070-01

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

1 FL OZ (30 mL)

NDC 70735-070-02

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

2 FL OZ (60 mL)

NDC 70735-070-03

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

3 FL OZ (89 mL)

NDC 70735-070-04

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

4 FL OZ (118 mL)

NDC 70735-070-06

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

6 FL OZ (177 mL)

NDC 70735-070-08

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

8 FL OZ (236 mL)

NDC 70735-070-16

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

16 FL OZ (473 mL)

NDC 70735-070-32

AspiCare

HAND SANITIZER

KILLS 99% OF GERMS*

Moisturizer Leaves Hands Smooth

MADE IN USA

32 FL OZ (946 mL)

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 or 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.


Advanced Ingredient Data


Raw Label Data

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