4ff8256f-876f-40fb-964c-df15c055deaf

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.

Active Ingredient

Active Ingredient

Benzalkonium Chloride 0.13%

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.

Inactive Ingredients

Inactive Ingredients

Aqua, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20,

Phenoxyethanol.

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

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

Warnings and Precautions (34071-1)

Warnings

For external use only.

Active Ingredient (55106-9)

Active Ingredient

Benzalkonium Chloride 0.13%

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.

Inactive Ingredients (Inactive ingredients)

Inactive Ingredients

Aqua, Propylene Glycol, Tocopheryl Acetate, Polysorbate 20,

Phenoxyethanol.

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

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)