Ndc- 63148-519

SPL v2

SPL

SPL Set ID c4f8bcd5-0593-4e37-bd91-9bf0dedbc676

Route

TOPICAL

Published

Effective Date 2020-06-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Isopropyl Alcohol (700 mg)

Inactive Ingredients

Water Ceteareth-6 Glycerin Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl- Isopropyl Myristate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-06-09

Description

Isopropyl Alcohol 70%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Isopropyl Alcohol 70%

Uses

for personal hand hygiene to help prevent the spread of bacterial, and can be used in place of hand washing if soap and water are not available.

Directions

Adults only
For occasional and personal use
Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Do Not Use

on children less than 2 months of age
on open skin wounds
on broken or damaged skin
if you are pregnant or breastfeeding

Label Copy

Active Ingredient

Isopropyl Alcohol 70%

Other Information

store at a temperature below 110°F (43°C)
may discolor certain fabrics or surfaces

Inactive Ingredients

Water, PEG-6, Fragrance, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer.

For External Use Only

flammable
keep away from source of heat or fire

Questions Or Comments?

1-866-695-3030

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not inhale.

Stop Use and Ask A Doctor If

irritation or redness develops and lasts.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Uses

for personal hand hygiene to help prevent the spread of bacterial, and can be used in place of hand washing if soap and water are not available.

Purpose

Antiseptic

Directions

Adults only
For occasional and personal use
Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Do Not Use (Do not use)

on children less than 2 months of age
on open skin wounds
on broken or damaged skin
if you are pregnant or breastfeeding

Label Copy

Active Ingredient (Active ingredient)

Isopropyl Alcohol 70%

Other Information (Other information)

store at a temperature below 110°F (43°C)
may discolor certain fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

Water, PEG-6, Fragrance, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer.

For External Use Only (For external use only)

flammable
keep away from source of heat or fire

Questions Or Comments? (Questions or comments?)

1-866-695-3030

When Using This Product (When using this product )

avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not inhale.

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

irritation or redness develops and lasts.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETEARETH-6", "unii": "2RJS3559D3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "700", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for personal hand hygiene to help prevent the spread of bacterial, and can be used in place of hand washing if soap and water are not available.", "Purpose": "Antiseptic", "Directions": "Adults only For occasional and personal use Rub thoroughly into hands for at least 30 seconds. Allow to dry.", "Do not use": "on children less than 2 months of age on open skin wounds on broken or damaged skin if you are pregnant or breastfeeding", "Active ingredient": "Isopropyl Alcohol 70%", "Other information": "store at a temperature below 110°F (43°C) may discolor certain fabrics or surfaces", "Inactive ingredients": "Water, PEG-6, Fragrance, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer.", "For external use only": "flammable keep away from source of heat or fire", "Questions or comments?": "1-866-695-3030", "When using this product ": "avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not inhale.", "Stop use and ask a doctor if": "irritation or redness develops and lasts.", "Keep out of reach of children.": "In case of accidental ingestion, get medical help or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:13.572427 · Updated: 2026-03-14T23:06:42.095401