Moisturizing Body Cleanser

Moisturizing Body Cleanser
SPL v5
SPL
SPL Set ID 8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8
Route
TOPICAL
Published
Effective Date 2019-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (17.5 ug)
Inactive Ingredients
Octenylsuccinic Acid Leucine Silicon Dioxide Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Polyoxyl 20 Cetostearyl Ether Glyceryl Stearate Se Peg-40 Sorbitan Peroleate Pyridoxine Hydrochloride Water Safflower Oil Stearic Acid Cetyl Alcohol Aspartic Acid Proline Glycine Tyrosine Phenylalanine Alanine Sodium Ascorbyl Phosphate Serine Valine Threonine Lysine Histidine Arginine Glutamic Acid .alpha.-tocopherol Acetate Niacinamide Ginger Kukui Nut Oil Glycerin Butylene Glycol Caprylyl Glycol Chlorphenesin Isopropyl Myristate Maltodextrin Isoleucine Phenoxyethanol Carthamus Tinctorius (safflower) Oleosomes Calcium Pantothenate Carbomer Interpolymer Type A (55000 Cps) Aminomethylpropanol .beta.-bisabolol Magnesium Disodium Edta

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-13
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

  • temporarily protects and helps relieve chapped or cracked skin
  • cleanses, moisturizes, and helps protect skin
  • it can be used on face, body and perineal area
Dosage and Administration

Directions

  • Apply cleanser to damp cloth or to skin/ perineal area and then gently wipe clean
  • No rinsing necessary
  • Apply as needed
  • Apply a protectant cream 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

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 51727-6

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate

Crosspolymer, Alanine, Aleurites

Moluccana (Kukui) Seed Oil,

Aminomethyl Propanol, Arginine, Aspartic

Acid, Bisabolol, Butylene Glycol, Calcium

Pantothenate (Vitamin B5), Caprylyl

Glycol, Carthamus Tinctorius (Safflower)

Oleosomes, Carthamus Tinctorius

(Safflower) Seed Oil, Ceteareth-20, Cetyl

Alcohol, Chlorphenesin, Disodium EDTA,

Fragrance, Glutamic Acid, Glycerin,

Glyceryl Stearate, Glycine, Histidine,

Isoleucine, Isopropyl Myristate, Leucine,

Lysine, Maltodextrin, Niacinamide

(Vitamin B3), PEG-40 Sorbitan Peroleate,

Phenoxyethanol, Phenylalanine, Proline,

Pyridoxine HCL (Vitamin B6), Serine,

Silica, Sodium Ascorbyl Phosphate

(Vitamin C), Sodium Hyaluronate, Sodium

Starch Octenylsuccinate, Stearic Acid,

Threonine, Tocopheryl Acetate (Vitamin

E), Tyrosine, Valine, Water, Zingiber

Officinale (Ginger) Root Extract

Section 51945-4

NDC 68599-0212-8

Thera

MOISTURIZING BODY CLEANSER

A no-rinse topical cleanser

Single Patient Use

NET CONTENTS 8 fl. oz (237 mL)

MFR # 53-MC8

Section 53413-1

Questions?

Call 1-800-777-4908

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active ingredient

Dimethicone 1.75%

Section 60561-8

Store at 40-95ºF (4-35ºC)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily protects and helps relieve chapped or cracked skin
  • cleanses, moisturizes, and helps protect skin
  • it can be used on face, body and perineal area
Dosage and Administration (34068-7)

Directions

  • Apply cleanser to damp cloth or to skin/ perineal area and then gently wipe clean
  • No rinsing necessary
  • Apply as needed
  • Apply a protectant cream 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

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Section 51727-6 (51727-6)

Inactive Ingredients: Acrylates/C10-30 Alkyl Acrylate

Crosspolymer, Alanine, Aleurites

Moluccana (Kukui) Seed Oil,

Aminomethyl Propanol, Arginine, Aspartic

Acid, Bisabolol, Butylene Glycol, Calcium

Pantothenate (Vitamin B5), Caprylyl

Glycol, Carthamus Tinctorius (Safflower)

Oleosomes, Carthamus Tinctorius

(Safflower) Seed Oil, Ceteareth-20, Cetyl

Alcohol, Chlorphenesin, Disodium EDTA,

Fragrance, Glutamic Acid, Glycerin,

Glyceryl Stearate, Glycine, Histidine,

Isoleucine, Isopropyl Myristate, Leucine,

Lysine, Maltodextrin, Niacinamide

(Vitamin B3), PEG-40 Sorbitan Peroleate,

Phenoxyethanol, Phenylalanine, Proline,

Pyridoxine HCL (Vitamin B6), Serine,

Silica, Sodium Ascorbyl Phosphate

(Vitamin C), Sodium Hyaluronate, Sodium

Starch Octenylsuccinate, Stearic Acid,

Threonine, Tocopheryl Acetate (Vitamin

E), Tyrosine, Valine, Water, Zingiber

Officinale (Ginger) Root Extract

Section 51945-4 (51945-4)

NDC 68599-0212-8

Thera

MOISTURIZING BODY CLEANSER

A no-rinse topical cleanser

Single Patient Use

NET CONTENTS 8 fl. oz (237 mL)

MFR # 53-MC8

Section 53413-1 (53413-1)

Questions?

Call 1-800-777-4908

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

Dimethicone 1.75%

Section 60561-8 (60561-8)

Store at 40-95ºF (4-35ºC)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:10.279459 · Updated: 2026-03-14T23:03:04.544899