consumer hand sanitizer; non-emergency; specially denatured ethyl alcohol = deferred grase active ingredient determination effective april…

consumer hand sanitizer; non-emergency; specially denatured ethyl alcohol = deferred grase active ingredient determination effective april 13, 2020; part333e for otc hand rub santizers (consumer)
SPL v1
SPL
SPL Set ID aa05201e-d0b7-61c8-e053-2a95a90a0f2f
Route
topical
Published
Effective Date 2020-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
limonene, (+)- water glycerin aloe vera leaf

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 and exessive heat above 40C (104F)
Inactive Ingredients

Aloe Barbadenisis (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

sunwavesanitizer.com

Active Ingredient

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 and exessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Aloe Barbadenisis (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

sunwavesanitizer.com

Active Ingredient

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: 2026-02-15T11:58:33.649414 · Updated: 2026-03-14T22:58:10.333472