SPL v3
SPL
SPL Set ID aabc441a-89ef-2bf8-e053-2a95a90aba2d
Route
TOPICAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Quillaja Saponaria Bark Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Polyoxyl 40 Hydrogenated Castor Oil Ethylhexylglycerin Aloe Vera Leaf Sodium Decylglucosides Hydroxypropylsulfonate Phenoxyethanol Glycerin Peg-8 Dimethicone Water Hyaluronic Acid Ppg-26-buteth-26

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-20

Description

Antimicrobial

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Antimicrobial

Pdp

MEDILAB

365

HAND SANITIZER FOAM

ANTI-BACTERIAL

ADVANCED FORMULA

KILLS 99.99%

OF GERMS

REGISTERED CERTIFIED

FDA GMP

FORMULA FACILITY

5 FL.OZ (150 ML)

Uses

*To help decrease bacterial on the skin. Recomended for repeated use as needed.

Stop Use

*Stop use and consult with doctor if irritation and redness develops, or if condition persists for more than 24 hours.

Warnings

For external use only.

Directions

* Pump a sufficient amount of foam into palm of hand.

* Rub thoroughly over all surfaces of both hands.

* Rub hands repeatedly until dry.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 104 OF.

Inactive Ingredients

Water, Glycerin, Hyaluronic Acid, Aloe Barbadensis Leaf Juice Powder, Quillaja Saponaria (Soapbark) Bark Extract, PEG-8 Dimethicone, Polyquaternium-7, PPG-26 Buteth-26, PEG-40 Hydrogenated Castor Oil, Sodium Decylglucosides Hydroxypropylsulfonate, Ethylhexylglycerin, Phenoxyethanol, Fragrance.

Keep Out of Reach of Children

In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.


Structured Label Content

Pdp (PDP)

MEDILAB

365

HAND SANITIZER FOAM

ANTI-BACTERIAL

ADVANCED FORMULA

KILLS 99.99%

OF GERMS

REGISTERED CERTIFIED

FDA GMP

FORMULA FACILITY

5 FL.OZ (150 ML)

Uses

*To help decrease bacterial on the skin. Recomended for repeated use as needed.

Purpose

Antimicrobial

Stop Use

*Stop use and consult with doctor if irritation and redness develops, or if condition persists for more than 24 hours.

Warnings

For external use only.

Directions

* Pump a sufficient amount of foam into palm of hand.

* Rub thoroughly over all surfaces of both hands.

* Rub hands repeatedly until dry.

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 104 OF.

Inactive Ingredients

Water, Glycerin, Hyaluronic Acid, Aloe Barbadensis Leaf Juice Powder, Quillaja Saponaria (Soapbark) Bark Extract, PEG-8 Dimethicone, Polyquaternium-7, PPG-26 Buteth-26, PEG-40 Hydrogenated Castor Oil, Sodium Decylglucosides Hydroxypropylsulfonate, Ethylhexylglycerin, Phenoxyethanol, Fragrance.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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