drug fact

Drug Facts

Composition & Product

Active Ingredients

chloroxylenol (0.5 g)

Inactive Ingredients

water carbomer copolymer type a trolamine edetate disodium d&c red no. 33 fd&c blue no. 1 fd&c yellow no. 5 alcohol fd&c yellow no. 6 fd&c red no. 40 polyoxyl 40 hydrogenated castor oil benzethonium chloride

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2012-06-18

Medication Information

Warnings and Precautions

For external use only

Flammable

When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid Contact with broken skin. Do not inhale or ingest.

Active Ingredient

Active Ingredient

Chloroxylenol 0.5%

Indications and Usage

Uses

To decrease bacteria on the skin that could cause diseases

Recommended for repeated use

Dosage and Administration

Directions

Wet hands thoroughly with product and allow to dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants

Description

Active Ingredient Chloroxylenol 0.5%

Section 44425-7

Other Information:

Do not store above 105F
May discolor some fabrics
Harmful to wood finishes and plastics

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

Section 50569-3

Stop use and ask a doctor if skin irritation develops

Section 51727-6

Inactive Ingredient:

Benzethonium Chloride, Alcohol, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate, may contain D and C Red No. 33, D and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

Section 51945-4

labe

Section 55105-1

Purpose

Antiseptic

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Flammable

When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid Contact with broken skin. Do not inhale or ingest.

Active Ingredient (55106-9)

Active Ingredient

Chloroxylenol 0.5%

Indications and Usage (34067-9)

Uses

To decrease bacteria on the skin that could cause diseases

Recommended for repeated use

Dosage and Administration (34068-7)

Directions

Wet hands thoroughly with product and allow to dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants

Section 44425-7 (44425-7)

Other Information:

Do not store above 105F
May discolor some fabrics
Harmful to wood finishes and plastics

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

Section 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation develops

Section 51727-6 (51727-6)

Inactive Ingredient:

Benzethonium Chloride, Alcohol, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate, may contain D and C Red No. 33, D and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

Section 51945-4 (51945-4)

labe

Section 55105-1 (55105-1)

Purpose

Antiseptic

Advanced Ingredient Data

[{"name": "CHLOROXYLENOL", "unii": "0F32U78V2Q", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER COPOLYMER TYPE A", "unii": "71DD5V995L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZETHONIUM CHLORIDE", "unii": "PH41D05744", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses To decrease bacteria on the skin that could cause diseases Recommended for repeated use", "34068-7": "Directions Wet hands thoroughly with product and allow to dry without wiping For children under 6, use only under adult supervision Not recommended for infants", "34071-1": "For external use only Flammable When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid Contact with broken skin. Do not inhale or ingest.", "44425-7": "Other Information: Do not store above 105F May discolor some fabrics Harmful to wood finishes and plastics", "50565-1": "Keep out of reach of children . In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away", "50569-3": "Stop use and ask a doctor if skin irritation develops", "51727-6": "Inactive Ingredient: Benzethonium Chloride, Alcohol, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, Triethanolamine, Tocopheryl Acetate, may contain D and C Red No. 33, D and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.", "51945-4": "labe", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredient Chloroxylenol 0.5%"}