49283-707-16 - DailyMed Details

49283-707-16

SPL v2

SPL

SPL Set ID 04de4392-74f6-7df8-e063-6294a90ae3b1

Route

TOPICAL

Published

Effective Date 2023-09-08

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 Completed Since 2021-03-17 Until 2027-12-31

Description

Ethyl Alcohol 70%v/v

Medication Information

Warnings and Precautions

• For external use only.

• Avoid contact with eyes or mucous membrane.

• Do not apply to wounds or damaged

skin with a heating pad or on a child

under 12 year of age.

Description

Ethyl Alcohol 70%v/v

Uses:

To decrease bacteria on the skin.

Section 50565-1

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

Section 50566-9

Condition persists for more than 72 hours.

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

Section 55105-1

Antimicrobial

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

• Spray two to three pumps or as

necessary to cover the affected area

not more than three to four times

daily.

Ask A Doctor Before Use If

If you have redness over affected area.

Footspa Antibacterial Pedi Spray 4 Oz

Footspa Antibacterial Pedi Spray 16 Oz

Footspa Antibacterial Pedi Spray 128 Oz

Structured Label Content

Uses: (USES:)

To decrease bacteria on the skin.

Warnings and Precautions (34071-1)

• For external use only.

• Avoid contact with eyes or mucous membrane.

• Do not apply to wounds or damaged

skin with a heating pad or on a child

under 12 year of age.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Condition persists for more than 72 hours.

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)

Section 55105-1 (55105-1)

Antimicrobial

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

• Spray two to three pumps or as

necessary to cover the affected area

not more than three to four times

daily.

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

If you have redness over affected area.

Footspa Antibacterial Pedi Spray 4 Oz (FOOTSPA - ANTIBACTERIAL PEDI SPRAY 4 oz)

Footspa Antibacterial Pedi Spray 16 Oz (FOOTSPA - ANTIBACTERIAL PEDI SPRAY 16 oz)

Footspa Antibacterial Pedi Spray 128 Oz (FOOTSPA - ANTIBACTERIAL PEDI SPRAY 128 oz)

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PEPPERMINT OIL", "unii": "AV092KU4JH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 11", "unii": "44F3HYL954", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES:": "To decrease bacteria on the skin.", "34071-1": "• For external use only. • Avoid contact with eyes or mucous membrane. • Do not apply to wounds or damaged skin with a heating pad or on a child under 12 year of age.", "50565-1": "If swallowed, get medical help, or contact a Poison Control Center right away.", "50566-9": "Condition persists for more than 72 hours.", "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).", "53413-1": "Contact us +1 (305) 623-4445", "55105-1": "Antimicrobial", "55106-9": "Ethyl Alcohol 70%v/v", "FLAMMABLE:": "Keep away from fire or flame.", "DIRECTIONS:": "Adults and children 12 years of age or older • Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.", "ASK A DOCTOR BEFORE USE IF": "If you have redness over affected area."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.402907 · Updated: 2026-03-14T23:13:32.363247