SPL v1
SPL
SPL Set ID 59c23743-1809-4b36-88fe-d6d71643c5ba
Route
TOPICAL
Published
Effective Date 2020-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Aloe Vera Leaf Carbomer Homopolymer, Unspecified Type Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-25

Description

For external use only: hands.  FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. When using this product ▪ Keep out of eyes. In case of contact with eyes, flush thoroughly with water ▪ Avoid contact with broken skin ▪ Do not inhale or ingest ▪ Stop use and ask a doctor if: irritation and redness develop or condition persists for more than 72 hours

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

For external use only: hands.  FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME. When using this product ▪ Keep out of eyes. In case of contact with eyes, flush thoroughly with water ▪ Avoid contact with broken skin ▪ Do not inhale or ingest ▪ Stop use and ask a doctor if: irritation and redness develop or condition persists for more than 72 hours

Uses

To decrease bacteria on the skin that could cause disease ▪ Recommended for repeated use

Warnings

For external use only: hands. 

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

When using this product ▪ Keep out of eyes. In case of contact with eyes, flush thoroughly with water

▪ Avoid contact with broken skin ▪ Do not inhale or ingest ▪ Stop use and ask a doctor if: irritation and

redness develop or condition persists for more than 72 hours

Packaging

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

Ethyl alcohol 70%

Other Information

Do not store above 105°F ▪ May discolor some fabrics ▪ Harmful to wood finishes and plastics.

70% ALCOHOL

Kills 99.99% of Germs

Aloe Vera & Vitamin E

Fragrance Free

*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

Distributed by: FOH Inc Miami, FL 33138

fohhealth.com

CRUELTY FREE

VEGAN

PARABEN FREE

NO SULFATES

MADE IN USA

Inactive Ingredients

Deionized Water, Aloe Vera Gel (Aloe Barbadensis Leaf Juice), Carbomer,

Triethanolamine, Vitamin E (Tocopheryl Acetate).

Keep Out of Reach of Children

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

away


Structured Label Content

Uses

To decrease bacteria on the skin that could cause disease ▪ Recommended for repeated use

Purpose

Antiseptic

Warnings

For external use only: hands. 

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

When using this product ▪ Keep out of eyes. In case of contact with eyes, flush thoroughly with water

▪ Avoid contact with broken skin ▪ Do not inhale or ingest ▪ Stop use and ask a doctor if: irritation and

redness develop or condition persists for more than 72 hours

Packaging

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

Ethyl alcohol 70%

Other Information

Do not store above 105°F ▪ May discolor some fabrics ▪ Harmful to wood finishes and plastics.

70% ALCOHOL

Kills 99.99% of Germs

Aloe Vera & Vitamin E

Fragrance Free

*Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds.

Distributed by: FOH Inc Miami, FL 33138

fohhealth.com

CRUELTY FREE

VEGAN

PARABEN FREE

NO SULFATES

MADE IN USA

Inactive Ingredients

Deionized Water, Aloe Vera Gel (Aloe Barbadensis Leaf Juice), Carbomer,

Triethanolamine, Vitamin E (Tocopheryl Acetate).

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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