aabc441a-89ef-2bf8-e053-2a95a90aba2d

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

Purpose

Antimicrobial

Description

Antimicrobial


Medication Information

Warnings

For external use only.

Uses

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

Purpose

Antimicrobial

Directions

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

* Rub thoroughly over all surfaces of both hands.

* Rub hands repeatedly until dry.

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.

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)

Stop Use

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

Active Ingredient

Benzalkonium Chloride 0.13%

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only.

Uses

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

Purpose

Antimicrobial

Directions

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

* Rub thoroughly over all surfaces of both hands.

* Rub hands repeatedly until dry.

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.

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)

Stop Use

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

Active Ingredient

Benzalkonium Chloride 0.13%

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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