49283-702-16

49283-702-16
SPL v2
SPL
SPL Set ID 3886a958-d035-ed15-e063-6294a90af1b5
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Polysorbate 20 Menthol Fd&c Blue No. 1 Camphor (synthetic) Peppermint Oil Eucalyptus Oil D&c Yellow No. 11 Dmdm Hydantoin

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

Ethyl Alcohol 70%v/v


Medication Information

Warnings and Precautions

For external use only.

Do not use in the eyes or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if the condition persists or gets worse.

Do not use longer than 1 week unless directed by a doctor.

For external use only.

Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age

Description

Ethyl Alcohol 70%v/v

Uses

First aid to help protect against bacterial contamination.

Section 50565-1

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

Section 51727-6

Water (Aqua), Camphor, Polysorbate 20, Menthol, DMDM Hydantoin, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, D&C Yellow No.11(CI 47000), FD&C Blue No.1 (CI 42090).

Section 53413-1

Contact us

+1 (305) 623-4445

Section 55105-1

Antiseptic

Section 55106-9

Ethyl Alcohol 70%v/v

Flammable:

Keep away from fire or flame.

Directions:

Adults and children 12 years of age or older

• Clean the affected area.

• Spray two to three pumps or as necessary to cover the affected area 1 or 3 times daily.

• May be covered with a sterile bandage.

• If bandaged, let dry first. Children under 12 years of age: do not use, consult a doctor.

Ask A Doctor Before Use If

If you have redness over affected area.

Footspa Antiseptic Pedi Spray 4 Oz

Footspa Antiseptic Pedi Spray 16 Oz

Footspa Antiseptic Pedi Spray 128 Oz


Structured Label Content

Uses

First aid to help protect against bacterial contamination.

Warnings and Precautions (34071-1)

For external use only.

Do not use in the eyes or apply over large areas of the body.

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and ask a doctor if the condition persists or gets worse.

Do not use longer than 1 week unless directed by a doctor.

For external use only.

Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water (Aqua), Camphor, Polysorbate 20, Menthol, DMDM Hydantoin, Mentha Piperita (Peppermint) Oil, Eucalyptus Globulus Leaf Oil, D&C Yellow No.11(CI 47000), FD&C Blue No.1 (CI 42090).

Section 53413-1 (53413-1)

Contact us

+1 (305) 623-4445

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Ethyl Alcohol 70%v/v

Flammable: (FLAMMABLE:)

Keep away from fire or flame.

Directions: (DIRECTIONS:)

Adults and children 12 years of age or older

• Clean the affected area.

• Spray two to three pumps or as necessary to cover the affected area 1 or 3 times daily.

• May be covered with a sterile bandage.

• If bandaged, let dry first. Children under 12 years of age: do not use, consult a doctor.

Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

If you have redness over affected area.

Footspa Antiseptic Pedi Spray 4 Oz (FOOTSPA - ANTISEPTIC PEDI SPRAY 4 oz)

Footspa Antiseptic Pedi Spray 16 Oz (FOOTSPA - ANTISEPTIC PEDI SPRAY 16 oz)

Footspa Antiseptic Pedi Spray 128 Oz (FOOTSPA - ANTISEPTIC PEDI SPRAY 128 oz)


Advanced Ingredient Data


Raw Label Data

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