SEREN GUARD SANITIZING WIPES- sanitizing wipes patch

SEREN GUARD Sanitizing Wipes by

Drug Labeling and Warnings

SEREN GUARD Sanitizing Wipes 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 Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

■ Hand sanitizing to decrease bacteria on the skin.
■ Recommended for hand sanitizing use.

Warnings

For external use only.

WHEN USING

When using this product, avoid contact with the eyes.
In case of contact, 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.

Directions

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

Other Information

■ Keep sealed and store below 0-30°C (32-38°F)
■ Avoid sun exposure and excessive heat above 40°C (104°F)

Inactive Ingredients

Aqua, Propylene Glycol, Tocophery Acetate,Polysorbate 20 ,
Phenoxyethanol.

Package Label - Principal Display Panel

80
COUNT

SEREN GUARD

Sanitizig Wipes

STERILIZATION RATE 99.9%

HYGIENIC STERILIZATION FOR HEALTH CARE

Alcohol Free

Skin Friendly Ingredients
Alcohol Free

STORAGE
Store in a cool and dry place.
Avoid direct sunlight.

DIRECTIONS
■Turn the cap counter clockwise to remove and peel off the seal.
■ Gently tug at the center wipe and feed it through the cap from the inside out.
■ Screw the cap back on and you are ready to use. Tilt to remove wipe one at a time.

Skin friendly ingredients.

ITEM CODE : SGNA-05

MATERIAL: NON-WOVEN
WIPES SIZE: 15X20CM
WIPES: 80 SHEET COUNT

Batch No: Printed on side.
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

Made in China

80 Count

160 Count

200 Count

res

INGREDIENTS AND APPEARANCE

SEREN GUARD SANITIZING WIPES 
sanitizing wipes patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79183-401
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: 79183-401-08	80 in 1 BOTTLE, DISPENSING	07/30/2020
1		4.9 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 79183-401-16	160 in 1 BOTTLE, DISPENSING	07/30/2020
2		4.9 g in 1 PATCH; Type 0: Not a Combination Product
3	NDC: 79183-401-20	200 in 1 BOTTLE, DISPENSING	07/30/2020
3		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	07/30/2020

Labeler - Prime Pace Products LLC (081214185)

Registrant - Prime Pace Products LLC (081214185)