Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bbd0772b-b464-43a6-e053-2a95a90a7ffc
Route
TOPICAL
Published
Effective Date 2021-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water .alpha.-tocopherol Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-01

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin.

Dosage and Administration

Apply 5 to 6 drops each use to clearn and protect hands

Work thoroughly onto hands and allow it to dry without wiping

Reapply as needed. Rpeat application increases effectiveness.

Description

Benzalkonium Chloride 0.13%

Section 50565-1

Children should be supervised when using this product

Section 50569-3

If irritation or redness develops or persists for 72 hours.

Section 50570-1

Avoid contact with eyes.

If eye contact occurs, rinse throughly with water.

Section 51727-6

Glycerin, Vitamin E, Proprietary blend of Metabolites, Deionized water.

Section 51945-4

Multiplex

Shuddi Antiseptic Disinfectant Hand Sanitizer

Kills 99.9% of Germs and Bacteria on Hands

Alcohol Free Bio-Organic

Multiplex Shuddi Hand sanitizer is a bio-organic product useful in sanitization and disinfection.

Key Features:

* Alcohol free liquid for hand sanitization & hand disinfection, having antimicrobial & germicidal property.

* Moisturizes using Glycerin and Vitamin E. non-combustible, non-staining, dye-free formula.

* Specially formulated blend of ingredients is safe on skin but tough on germs.

Manufactured by

Multiplex Bio-Tech Pvt. Ltd

No. 180, 1st Main Road, Mahalakshmi Layout Extension,

Bengaluru- 560 086. India

Ph.: 080-2349 7464, 2349 4406, 2349 7360

Email: [email protected]

Website: www.shuddi.com

Good Manufacturing Practice (GMP)

Xx fl oz (XX mL) NDC: 81105-001-XX; 81105-002-XX

Section 53413-1

Call customer care cell: 080-2349-3692

Section 55105-1

Hand & Skin Antiseptic

Section 55106-9

Benzalkonium Chloride 0.13%


Structured Label Content

Indications and Usage (34067-9)

Hand & Skin Antiseptic to help decrease pathogens (germs) on the skin.

Dosage and Administration (34068-7)

Apply 5 to 6 drops each use to clearn and protect hands

Work thoroughly onto hands and allow it to dry without wiping

Reapply as needed. Rpeat application increases effectiveness.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Children should be supervised when using this product

Section 50569-3 (50569-3)

If irritation or redness develops or persists for 72 hours.

Section 50570-1 (50570-1)

Avoid contact with eyes.

If eye contact occurs, rinse throughly with water.

Section 51727-6 (51727-6)

Glycerin, Vitamin E, Proprietary blend of Metabolites, Deionized water.

Section 51945-4 (51945-4)

Multiplex

Shuddi Antiseptic Disinfectant Hand Sanitizer

Kills 99.9% of Germs and Bacteria on Hands

Alcohol Free Bio-Organic

Multiplex Shuddi Hand sanitizer is a bio-organic product useful in sanitization and disinfection.

Key Features:

* Alcohol free liquid for hand sanitization & hand disinfection, having antimicrobial & germicidal property.

* Moisturizes using Glycerin and Vitamin E. non-combustible, non-staining, dye-free formula.

* Specially formulated blend of ingredients is safe on skin but tough on germs.

Manufactured by

Multiplex Bio-Tech Pvt. Ltd

No. 180, 1st Main Road, Mahalakshmi Layout Extension,

Bengaluru- 560 086. India

Ph.: 080-2349 7464, 2349 4406, 2349 7360

Email: [email protected]

Website: www.shuddi.com

Good Manufacturing Practice (GMP)

Xx fl oz (XX mL) NDC: 81105-001-XX; 81105-002-XX

Section 53413-1 (53413-1)

Call customer care cell: 080-2349-3692

Section 55105-1 (55105-1)

Hand & Skin Antiseptic

Section 55106-9 (55106-9)

Benzalkonium Chloride 0.13%


Advanced Ingredient Data


Raw Label Data

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