version2: this is intended to correct and replace version 1 of setid item ending "...adee2"

version2: this is intended to correct and replace version 1 of setid item ending "...adee2"
SPL v2
SPL
SPL Set ID aa051319-09f1-57d5-e053-2a95a90adee2
Route
topical
Published
Effective Date 2020-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.492 L)
Inactive Ingredients
water aloe vera leaf limonene, (+)- glycerin

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-05
Purpose

Antiseptic

Description

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

Medication Information

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Purpose

Antiseptic

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

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

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.

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

Active Ingredient(s)

Alcohol 70% v/v

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

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Purpose

Antiseptic

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.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing or excessive heat above 40C (104F).
Inactive Ingredients (Inactive ingredients)

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

Use(s)

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

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

Active Ingredient(s)

Alcohol 70% v/v

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:33.647171 · Updated: 2026-03-14T22:58:10.333472