Antimicrobial Body Cleanser

Antimicrobial Body Cleanser
SPL v6
SPL
SPL Set ID 8ff06cea-3427-5b40-e053-2995a90a0634
Route
TOPICAL
Published
Effective Date 2019-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1.3 ug)
Inactive Ingredients
Water Proline Valine Leucine Niacinamide .alpha.-tocopherol Acetate Lysine Glycerin Polysorbate 20 Phenylalanine Arginine Caprylyl Glycol Chlorphenesin Sodium Ascorbyl Phosphate Octenylsuccinic Acid Threonine Glycine Edetic Acid Histidine Isoleucine Carthamus Tinctorius (safflower) Oleosomes Calcium Pantothenate Maltodextrin Pyridoxine Hydrochloride Aspartic Acid Glutamic Acid Alanine Tyrosine Serine Butylene Glycol Phenoxyethanol Silicon Dioxide Aloe Vera Leaf Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-12

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this product

  • do not get into eyes

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Indications and Usage

Uses

a no-rinse topical antiseptic for reducing and inhibiting bacterial growth.

Dosage and Administration

Directions

  • Spray soiled and/or odorous (body and/or perineal) areas
  • Gently wipe clean
  • Repeat as necessary until all soils are removed and skin is clean
  • Pat dry
  • No rinsing necessary
  • Apply a protectant cream or paste as necessary
Description

Drug Facts

Section 42229-5

Drug Facts

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

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours
Section 51727-6

Inactive ingredients

Alanine, Aloe Barbadensis Leaf Juice,

Arginine, Aspartic Acid, Butylene Glycol,

Calcium Pantothenate (Vitamin B5),

Caprylyl Glycol, Carthamus Tinctorius

(Safflower) Oleosomes, Chlorphenesin,

Fragrance, Glutamic Acid, Glycerin,

Glycine, Histidine, Isoleucine, Leucine,

Lysine, Maltodextrin, Niacinamide

(Vitamin B3), Phenoxyethanol,

Phenylalanine, Polysorbate 20, Proline,

Pyridoxine HCL (Vitamin B6), Serine,

Silica, Sodium Ascorbyl Phosphate

(Vitamin C), Sodium Hyaluronate,

Sodium Starch Octenylsuccinate,

Tetrasodium EDTA, Threonine,

Tocopheryl Acetate (Vitamin E), Tyrosine,

Valine, Water (may contain Citric Acid,

Sodium Hydroxide)

Section 51945-4

NDC 68599-0214-4



McKesson



Thera



ANTIMICROBIAL BODY CLEANSER



A no-rinse topical cleanser for reducing and inhibiting bacterial growth.



Single Patient Use



NET CONTENTS 4 fl. oz (118 mL)



MFR # 53-AC4

Section 53413-1

Questions?

Call 1-800-777-4908

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.13%

Section 60561-8

Store at 40-95ºF (4-35ºC)


Structured Label Content

Indications and Usage (34067-9)

Uses

a no-rinse topical antiseptic for reducing and inhibiting bacterial growth.

Dosage and Administration (34068-7)

Directions

  • Spray soiled and/or odorous (body and/or perineal) areas
  • Gently wipe clean
  • Repeat as necessary until all soils are removed and skin is clean
  • Pat dry
  • No rinsing necessary
  • Apply a protectant cream or paste as necessary
Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product

  • do not get into eyes

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 42229-5 (42229-5)

Drug Facts

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)

Stop use and ask a doctor if

  • irritation and redness develop
  • condition persists for more than 72 hours
Section 51727-6 (51727-6)

Inactive ingredients

Alanine, Aloe Barbadensis Leaf Juice,

Arginine, Aspartic Acid, Butylene Glycol,

Calcium Pantothenate (Vitamin B5),

Caprylyl Glycol, Carthamus Tinctorius

(Safflower) Oleosomes, Chlorphenesin,

Fragrance, Glutamic Acid, Glycerin,

Glycine, Histidine, Isoleucine, Leucine,

Lysine, Maltodextrin, Niacinamide

(Vitamin B3), Phenoxyethanol,

Phenylalanine, Polysorbate 20, Proline,

Pyridoxine HCL (Vitamin B6), Serine,

Silica, Sodium Ascorbyl Phosphate

(Vitamin C), Sodium Hyaluronate,

Sodium Starch Octenylsuccinate,

Tetrasodium EDTA, Threonine,

Tocopheryl Acetate (Vitamin E), Tyrosine,

Valine, Water (may contain Citric Acid,

Sodium Hydroxide)

Section 51945-4 (51945-4)

NDC 68599-0214-4



McKesson



Thera



ANTIMICROBIAL BODY CLEANSER



A no-rinse topical cleanser for reducing and inhibiting bacterial growth.



Single Patient Use



NET CONTENTS 4 fl. oz (118 mL)



MFR # 53-AC4

Section 53413-1 (53413-1)

Questions?

Call 1-800-777-4908

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.13%

Section 60561-8 (60561-8)

Store at 40-95ºF (4-35ºC)


Advanced Ingredient Data


Raw Label Data

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