Version 2: Correction Intended To Replace Setid Submission Ending "..ab88e"

SPL v2

SPL

SPL Set ID a9b89b7a-e789-8afc-e053-2a95a90ab88e

Route

TOPICAL

Published

Effective Date 2020-07-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Isopropyl Alcohol (0.492 L)

Inactive Ingredients

Water Aloe Vera Leaf Glycerin Limonene, (+)-

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-07-05

Description

Alcohol 70% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Alcohol 70% v/v

Use(s)

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

Section 51945-4

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

Other Information

Store between 15-30C (59-86F)
Avoid freezing or excessive heat above 40C (104F).

Active Ingredient(s)

Alcohol 70% v/v

Inactive Ingredients

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

When Using This Product

keep out of eyes, ears, and mouth. In case 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.

Section 51945-4 (51945-4)

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

Manufactured By: (Manufactured by:)

Sun Wave Wellness, LLC

1419 Chaffee Drive #101

Titusville, FL 32780-7933

Other Information (Other information)

Store between 15-30C (59-86F)
Avoid freezing or excessive heat above 40C (104F).

Active Ingredient(s)

Alcohol 70% v/v

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)

keep out of eyes, ears, and mouth. In case 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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "0.492", "strengthDenominator": "1.893", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "1.325", "strengthDenominator": "1.893", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "0.019", "strengthDenominator": "1.893", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.038", "strengthDenominator": "1.893", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "0.019", "strengthDenominator": "1.893", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}]

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", "Other information": "Store between 15-30C (59-86F) Avoid freezing or excessive heat above 40C (104F).", "Active Ingredient(s)": "Alcohol 70% v/v", "Inactive ingredients": "Aloe Barbadensis (leaf) Extract, Fragrance, Glycerin, Purified Water", "When using this product": "keep out of eyes, ears, and mouth. In case 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: 2026-02-15T11:58:33.645111 · Updated: 2026-03-14T22:58:10.333472