SPL v5
SPL
SPL Set ID 11ca4b84-7fc6-491f-b2e7-44c49b428777
Route
TOPICAL
Published
Effective Date 2019-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Carbomer 980 Glycerin Propylene Glycol Isopropyl Myristate Aloe Vera Leaf Aminomethylpropanol Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-01-01

Description

Isopropyl Alcohol 70.0%

Purpose

Antimicrobial


Medication Information

Warnings and Precautions

Flammable. Keep away from heat and flame.

Purpose

Antimicrobial

Description

Isopropyl Alcohol 70.0%

Uses

To help decrease bacteria on the skin. Recommended for repeat use.

Section 51945-4

Warnings

For external use only.

Directions

• Wet hands thoroughly with product and allow to dry without wiping

• For children under 6, use only under adult supervision

• Not recommended for infants

Active Ingredient

Isopropyl Alcohol 70.0%

Inactive Ingredients

aloe barbadensis powder, amino-methyl-propanol, carbomer, glycerin,

isopropyl myristate, propylene glycol, tocopheryl acetate, water

When Using This Product

• Keep out of eyes. In case of contact, rinse eyes thoroughly with water

• Avoid contact with broken skin

• Do not inhale or ingest

Stop Use and Ask A Doctor If

If irritation or redness develops.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

To help decrease bacteria on the skin. Recommended for repeat use.

Warnings and Precautions (34071-1)

Flammable. Keep away from heat and flame.

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

For external use only.

Directions

• Wet hands thoroughly with product and allow to dry without wiping

• For children under 6, use only under adult supervision

• Not recommended for infants

Active Ingredient (Active ingredient)

Isopropyl Alcohol 70.0%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis powder, amino-methyl-propanol, carbomer, glycerin,

isopropyl myristate, propylene glycol, tocopheryl acetate, water

When Using This Product (When using this product)

• Keep out of eyes. In case of contact, rinse eyes thoroughly with water

• Avoid contact with broken skin

• Do not inhale or ingest

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

If irritation or redness develops.

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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