SPL v8
SPL
SPL Set ID 16650277-fa62-485e-9a82-7763d2b50168
Route
TOPICAL
Published
Effective Date 2022-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 mg)
Inactive Ingredients
Water Aloe Vera Flower Propylene Glycol Triethylene Glycol Polysorbate 20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

When using this product■ Avoid contact with

eyes. ■ In case of eye contact, flush with water.

■ Call doctor if irritation persists.

Indications and Usage

Uses

■ For sanitizing to reduce bacteria on the skin.

Dosage and Administration

Directions

■ Apply 1 - 2 pump to dry hands, rub into skin.

■ Supervise children in the use of this product.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. ■ If swallowed,

get medical help or contact a Poison Control

Center right away.

Section 51727-6

Inactive ingredients

Purified Water, Aloe Vera, Propylene Glycol,

Triethylene Glycol, Polysorbate-20.

Section 55105-1

Purpose

Antibacterial

Section 55106-9

Active Ingredient

Benzalkonium Chloride, 0.13%

Principal Display Panel

GentleCare

Solutions

Foaming

Hand & Skin

Sanitizer

  • Kills 99.99% of Germs
  • Moisturizes & Conditions
  • Alcohol Free, Sting Free
  • Fragrance Free

with Aloe Vera

1.7 fl. oz. (50 mL)

Sold by:

GentleCare

Solutions

A division of:

Paragon Solutions US, Inc.

New Hill, NC 27562

www.gentlecare.us

Questions?

Call Us Toll Free

1.800.262.8670

Monday to Friday

9:00 am to 4:00 pm EST

1.7 FL OZ

7.5 FL OZ

16.5 FL OZ

1 GAL

res

Structured Label Content

Indications and Usage (34067-9)

Uses

■ For sanitizing to reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions

■ Apply 1 - 2 pump to dry hands, rub into skin.

■ Supervise children in the use of this product.

Warnings and Precautions (34071-1)

Warnings

For external use only

When using this product■ Avoid contact with

eyes. ■ In case of eye contact, flush with water.

■ Call doctor if irritation persists.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. ■ If swallowed,

get medical help or contact a Poison Control

Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Purified Water, Aloe Vera, Propylene Glycol,

Triethylene Glycol, Polysorbate-20.

Section 55105-1 (55105-1)

Purpose

Antibacterial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride, 0.13%

Principal Display Panel

GentleCare

Solutions

Foaming

Hand & Skin

Sanitizer

  • Kills 99.99% of Germs
  • Moisturizes & Conditions
  • Alcohol Free, Sting Free
  • Fragrance Free

with Aloe Vera

1.7 fl. oz. (50 mL)

Sold by:

GentleCare

Solutions

A division of:

Paragon Solutions US, Inc.

New Hill, NC 27562

www.gentlecare.us

Questions?

Call Us Toll Free

1.800.262.8670

Monday to Friday

9:00 am to 4:00 pm EST

1.7 FL OZ

7.5 FL OZ

16.5 FL OZ

1 GAL

res

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:43.257613 · Updated: 2026-03-14T23:11:28.912883