Active Ingredients And Purpose
Active Ingredient
Benzethonium Chloride, 0.1%
Purpose
Antimicrobial Agent
Sanitizing Hand
- Manufacturer
- BELLA BRANDS INC
- Effective date
- 2020-11-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:33:55
Key Label Information#
Uses
Use
for moisturizing hands and decreasing bacteria on the skin.
Warnings
Warnings
- For external use only. - Do not use if you are allergic to any of the ingredients. - When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water. - Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.
Directions And Dosage
Directions For Use
- Press dispensing pump to release product into hands, and rub thoroughly around both sides of hands and between fingers. Do not wipe off. Let air dry. - For adults and children 2 years and over. - For children under 2 years of age, consult a doctor before use
Other Label Information
Inactive Ingredients
Water, Ethyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylic/ Capric Triglyceride, Potassium Cetyl Phosphate, Sorbitan Isostearate, Diheptyl Succinate & Capryloyl Glycerin/Sebacic Acid Copolymer, Stearic Acid, Chlorohexidine Gluconate, Carbomer, Polysorbate 20, Aminomethyl Propanol, Tetrasodium EDTA, Camellia Sinensis (Green Tea) Extract Organic Ingredient , Glycirrhiza Glabra (Licorice) Root Extract , Aloe Vera Barbadensis Leaf Juice , Chamomilla Recutita (Matricaria) Flower Extract , Phenoxyethanol, Ethylglycerin, Fragrance (Naturally Derived)
PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label
PURIGEN™ Sanitizing Hand Lotion Kills 99.9% of Germs Safe for Sensitive Skin Dual Use Sanitizer & Moisturizer Paraben Free No Artificial Fragrance Made with Organic Ingredients 13.5 fl oz (400 ml)
Label Images#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 80994-002-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4a7b-a426-e053-dadaa90af4c2 | Sanitizing Hand |
| 80994-002-02 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4a7b-a426-e053-dadaa90af4c2 | Sanitizing Hand |
| 80994-002-03 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4a7b-a426-e053-dadaa90af4c2 | Sanitizing Hand |
| 80994-002-04 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4a7b-a426-e053-dadaa90af4c2 | Sanitizing Hand |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80994-002-01 | Sanitizing Hand | 250 mL in 1 BOTTLE | LOTION | 250 | 1 | |
| 80994-002-02 | Sanitizing Hand | 400 mL in 1 BOTTLE | LOTION | 400 | 1 | |
| 80994-002-03 | Sanitizing Hand | 3785 mL in 1 BOTTLE | LOTION | 3785 | 1 | |
| 80994-002-04 | Sanitizing Hand | 1.2 mL in 1 PACKET | LOTION | 1.2 | 1 | |
| 80994-002-04 | Sanitizing Hand | 150 in 1 BOX | LOTION | 150 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- Sanitizing Hand
- BENZETHONIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80994-002 | 80994-002-01, 80994-002-02, 80994-002-03, 80994-002-04 |
Ingredients#
Complete SPL Sections#
SPL UNCLASSIFIED SECTION
Drug Facts:
Active Ingredient
Benzethonium Chloride, 0.1%
Purpose
Antimicrobial Agent
Use
for moisturizing hands and decreasing bacteria on the skin.
Warnings
- For external use only. - Do not use if you are allergic to any of the ingredients. - When using this product, do not get into eyes. If contact occurs, rinse thoroughly with water. - Stop use and consult a doctor if irritation or rash develops and continues for more than 72 hours.
Inactive Ingredients
Water, Ethyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, Caprylic/ Capric Triglyceride, Potassium Cetyl Phosphate, Sorbitan Isostearate, Diheptyl Succinate & Capryloyl Glycerin/Sebacic Acid Copolymer, Stearic Acid, Chlorohexidine Gluconate, Carbomer, Polysorbate 20, Aminomethyl Propanol, Tetrasodium EDTA, Camellia Sinensis (Green Tea) Extract Organic Ingredient , Glycirrhiza Glabra (Licorice) Root Extract , Aloe Vera Barbadensis Leaf Juice , Chamomilla Recutita (Matricaria) Flower Extract , Phenoxyethanol, Ethylglycerin, Fragrance (Naturally Derived)
Directions For Use
- Press dispensing pump to release product into hands, and rub thoroughly around both sides of hands and between fingers. Do not wipe off. Let air dry. - For adults and children 2 years and over. - For children under 2 years of age, consult a doctor before use
PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label
PURIGEN™ Sanitizing Hand Lotion Kills 99.9% of Germs Safe for Sensitive Skin Dual Use Sanitizer & Moisturizer Paraben Free No Artificial Fragrance Made with Organic Ingredients 13.5 fl oz (400 ml)