NOVAPUR CREAMY MOISTURIZING HAND SANITIZER- benzalkonium chloride gel

Novapur Creamy Moisturizing Hand Sanitizer by

Drug Labeling and Warnings

Novapur Creamy Moisturizing Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Les Entreprises Stefmar Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Benzalkonium Chloride 0.15% w/w

Purpose

Antimicrobial

Use

For hand-washing to decrease bacteria on the skin, only when water is not available. For occasional personal domestic use.

Warnings

For external use only.

Do not use

• in children less than 2 years old
• on open wounds

WHEN USING

When using this product

• do not get into eyes.
• if contact occurs, rinse thoroughly with water.

.

STOP USE

Stop use and ask a doctor if

irritation and redness develops.

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.

Directions

Directions

• Supervise children when they use this product
• Rub thoroughly into hands for at least 30 seconds and allow to dry

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aqua, Caprylic/Capric Triglyceride, Propylene glycol, Phenoxyethanol, Sodium polyacrylate, Ethylhexylglycerin, Aloe barbadensis leaf juice, Tocopherol

Package Label - Principal Display Panel

500 mL NDC: 71316-100-50

150 mL NDC: 71316-100-15

INGREDIENTS AND APPEARANCE

NOVAPUR CREAMY MOISTURIZING HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71316-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71316-100-15	150 mL in 1 TUBE; Type 0: Not a Combination Product	08/23/2021
2	NDC: 71316-100-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2021
3	NDC: 71316-100-04	40 mL in 1 TUBE; Type 0: Not a Combination Product	08/23/2021
4	NDC: 71316-100-08	80 mL in 1 TUBE; Type 0: Not a Combination Product	08/23/2021
5	NDC: 71316-100-90	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2021
6	NDC: 71316-100-95	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/23/2021

Labeler - Les Entreprises Stefmar Inc (240496385)

Establishment
Name	Address	ID/FEI	Business Operations
Les Entreprises Stefmar Inc		240496385	manufacture(71316-100)