SPL v4
SPL
SPL Set ID 4ff8256f-876f-40fb-964c-df15c055deaf
Route
TOPICAL
Published
Effective Date 2020-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Propylene Glycol .alpha.-tocopherol Acetate Polysorbate 20 Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-23

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses ■ Hand Sanitizer to decrease bacteria on skin.

        ■ Recommended for repeated use.

Dosage and Administration

Directions  ■ Thoroughly wipe hands as desired.

                 ■ Allow to dry without wiping.

                 ■ Discard wipe after use.

                 ■ Do not flush.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Discontinue use if irritation and redness develop. If the condition

persists for more than 72 hours, consult a Physician.

Section 50567-7

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active Ingredient

Benzalkonium Chloride 0.13%

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: [email protected]

ITEM CODE: SGNA-02

6  970366 697128

Made in China

80 Wipes

50 Wipes

res


Structured Label Content

Indications and Usage (34067-9)

Uses ■ Hand Sanitizer to decrease bacteria on skin.

        ■ Recommended for repeated use.

Dosage and Administration (34068-7)

Directions  ■ Thoroughly wipe hands as desired.

                 ■ Allow to dry without wiping.

                 ■ Discard wipe after use.

                 ■ Do not flush.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Discontinue use if irritation and redness develop. If the condition

persists for more than 72 hours, consult a Physician.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Inactive Ingredients

Aqua, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20,

Phenoxyethanol.

Package Label Principal Display Panel (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: [email protected]

ITEM CODE: SGNA-02

6  970366 697128

Made in China

80 Wipes

50 Wipes

res


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)