Version 2: Correction

SPL v2

SPL

SPL Set ID a9b5edf7-6837-ba04-e053-2995a90ac3e6

Route

TOPICAL

Published

Effective Date 2020-04-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Isopropyl Alcohol (70 mL)

Inactive Ingredients

Limonene, (+)- Water Glycerin Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-05

Description

To help reduce bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

To help reduce bacteria on the skin. For use when soap and water are not available.

Use(s)

To help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

on children less than 2 months of age
on open skin wounds
around eyes
in ears and mouth

Drug Facts

Manufactured By:

Sun Wave Wellness, LLC

1419 Chaffee Drive #101

Titusville, FL 32780-7933

sunwavesanitizer.com

Active Ingredient

Alcohol 70% v/v

Other Information

Store between 15-30C (59-86F)
Avoid freezing and exessive heat above 40C (104F)

Inactive Ingredients

Aloe Barbadenisis (leaf) Extract, Fragrance, Glycerin, Purified Water

When Using This Product

keep out of eyes, ears, and mouth.

Incase of contact with eyes, rinse eyes thoroughly with water.

avoid contact with broken skin
do not inhale or ingest

Stop Use and Ask A Doctor If

irritation or rash occurs.

Keep Out of Reach of Children.

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

Structured Label Content

Use(s)

To help reduce bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

on children less than 2 months of age
on open skin wounds
around eyes
in ears and mouth

Drug Facts

Manufactured By: (Manufactured by:)

Sun Wave Wellness, LLC

1419 Chaffee Drive #101

Titusville, FL 32780-7933

sunwavesanitizer.com

Active Ingredient

Alcohol 70% v/v

Other Information (Other information)

Store between 15-30C (59-86F)
Avoid freezing and exessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

Aloe Barbadenisis (leaf) Extract, Fragrance, Glycerin, Purified Water

When Using This Product (When using this product)

keep out of eyes, ears, and mouth.

Incase of contact with eyes, rinse eyes thoroughly with water.

avoid contact with broken skin
do not inhale or ingest

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

irritation or rash occurs.

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

[{"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "26", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "To help reduce bacteria on the skin. For use when soap and water are not available.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Do not use": "on children less than 2 months of age on open skin wounds around eyes in ears and mouth", "Manufactured by:": "Sun Wave Wellness, LLC 1419 Chaffee Drive #101 Titusville, FL 32780-7933 sunwavesanitizer.com", "Active Ingredient": "Alcohol 70% v/v", "Other information": "Store between 15-30C (59-86F) Avoid freezing and exessive heat above 40C (104F)", "Inactive ingredients": "Aloe Barbadenisis (leaf) Extract, Fragrance, Glycerin, Purified Water", "When using this product": "keep out of eyes, ears, and mouth. Incase of contact with eyes, rinse eyes thoroughly with water. avoid contact with broken skin do not inhale or ingest", "Stop use and ask a doctor if": "irritation or rash occurs.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:33.644035 · Updated: 2026-03-14T22:58:10.333472