Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ab89b8fa-126e-418d-e053-2a95a90a2eeb
Route
TOPICAL
Published
Effective Date 2020-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 g)
Inactive Ingredients
Rosemary Oil Paeonia Suffruticosa Root Bark Calendula Officinalis Flower Aloe Vera Leaf Glycerin Trolamine Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-29

Description

alcohol


Medication Information

Warnings and Precautions

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

Dosage and Administration

for external use only

Description

alcohol

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

Water, Glycerin, butylene glycol, carbomer, triethanolamine, rosmarinus officinalis (rosemary) leaf extract, paeonia suffruticosa bark extract, aloe barbadensis leaf extract, calendula officianalis flower extract

Section 51945-4

Section 55105-1

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin

recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

Section 55106-9

alcohol


Structured Label Content

Indications and Usage (34067-9)

Apply to clean, dry hands. Apply sufficient amount to thoroughly wet all surfaces of hands and fingers. Rub onto hands until dry.

Supervise children in the use of this product.

Dispense appropriate amount on your palm and thoroughly spread on both hands and rub into the skin until dry

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

Water, Glycerin, butylene glycol, carbomer, triethanolamine, rosmarinus officinalis (rosemary) leaf extract, paeonia suffruticosa bark extract, aloe barbadensis leaf extract, calendula officianalis flower extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

instant hand antiseptic to decrease bacteria on the skin

recommended for repeated use

hand sanitizer to help reduce bacteria on the skin

Section 55106-9 (55106-9)

alcohol


Advanced Ingredient Data


Raw Label Data

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