SEREN GUARD- sanitizing wipes patch

SEREN GUARD by

Drug Labeling and Warnings

SEREN GUARD by is a Otc medication manufactured, distributed, or labeled by Prime Pace Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient
Benzalkonium Chloride 0.13%

PURPOSE

Purpose
Antimicrobial

INDICATIONS & USAGE

Uses ■ Hand Sanitizer to decrease bacteria on skin.

        ■ Recommended for repeated use.

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product keep out of eyes, ears, and mouth.
In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Discontinue use if irritation and redness develop. If the condition
persists for more than 72 hours, consult a Physician.

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.

DOSAGE & ADMINISTRATION

Directions  ■ Thoroughly wipe hands as desired.
                 ■ Allow to dry without wiping.
                 ■ Discard wipe after use.
                 ■ Do not flush.

STORAGE AND HANDLING

Other Information

■ Keep sealed and store between 0-30°C (32 - 86°F)
■ For External Use Only. Avoid sun exposure and excessive heat above 40°C

Inactive ingredients

Inactive Ingredients
Aqua, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20,
Phenoxyethanol.

Package Label - Principal Display Panel

SEREN GUARD                                           80
                                                              WIPES     

Alcohol Free                        Skin friendly Ingredients

SEREN GUARD                           80
                            WIPES

Sanitizing Wipes
STERILIZATION RATE 99.9%

USAGE
Click open the lid and peel back the resealable label.
Pull a sterilized wipe for sanitizing hands.
Reseal label after use to prevent the wipes from drying.

Batch No: Printed on bag.

Distributed By: Prime Pace Products LLC, 36181 East Lake Rd, Suite 302, Palm Harbor, FL 34685, USA

Toll Free Number: 866-518-1984

Email: info@primepaceproducts.com

ITEM CODE: SGNA-02

6  970366 697128

Made in China

80 Wipes

50 Wipes

res

INGREDIENTS AND APPEARANCE

SEREN GUARD 
sanitizing wipes patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79183-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79183-001-80	80 in 1 BAG	06/23/2020
1		4.9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 79183-001-50	50 in 1 BAG	06/23/2020
2		4.9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2020

Labeler - Prime Pace Products LLC (081214185)

Registrant - Prime Pace Products LLC (081214185)