50563-429/jas21fl5

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Water Polyacrylamide (1500 Mw) Laureth-7 Phenoxyethanol Benzyl Alcohol Benzoic Acid Citric Acid Monohydrate Butyrospermum Parkii (shea) Butter Unsaponifiables .alpha.-tocopherol Acetate Fd&c Red No. 4 Fd&c Yellow No. 5 Fd&c Blue No. 1 Mineral Oil Glyceryl Stearate Se Peg-100 Stearate C13-14 Isoparaffin Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-03-27

Medication Information

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%

Use

■ To help reduce the bacteria on the skin

Section 50565-1

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Section 50566-9

Stop use and ask a doctor if skin irritation develops.

Section 51945-4

Warnings

For external use only

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Directions

Apply a small amount to palm and rub hands together thoroughly

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May doscolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Benzyl Alcohol, Fragrance (Parfum), C13-14 Isoparaffin, Laureth-7, Benoic Acid, Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1

Structured Label Content

Use

■ To help reduce the bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation develops.

Section 51945-4 (51945-4)

Purpose

Antibacterial

Warnings (WARNINGS)

For external use only

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Directions

Apply a small amount to palm and rub hands together thoroughly

Active Ingredient

Benzalkonium Chloride 0.13%

Other Information

Do not store above 105F

May doscolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients (Inactive ingredients)

Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Benzyl Alcohol, Fragrance (Parfum), C13-14 Isoparaffin, Laureth-7, Benoic Acid, Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYACRYLAMIDE (1500 MW)", "unii": "5D6TC4BRWV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURETH-7", "unii": "Z95S6G8201", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES", "unii": "0C9AC7D6XU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C13-14 ISOPARAFFIN", "unii": "E4F12ROE70", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "■ To help reduce the bacteria on the skin", "50565-1": "Keep out of reach of children. In case of accidenta ingestion, seek professional assistance or contact a Poison Control Center immdiately.", "50566-9": "Stop use and ask a doctor if skin irritation develops.", "Purpose": "Antibacterial", "WARNINGS": "For external use only When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.", "Directions": "Apply a small amount to palm and rub hands together thoroughly", "Active Ingredient": "Benzalkonium Chloride 0.13%", "Other Information": "Do not store above 105F May doscolor some fabrics Harmful to wood finishes and plastics", "Inactive ingredients": "Water, Cetearyl Alcohol, Mineral Oil, Glyceryl Stearate, Glycerin, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Benzyl Alcohol, Fragrance (Parfum), C13-14 Isoparaffin, Laureth-7, Benoic Acid, Citric Acid, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Red 4, Yellow 5, Blue 1"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information