Moisturizing Body Cream

Moisturizing Body Cream
SPL v4
SPL
SPL Set ID 96886b33-44d4-5a2a-e053-2a95a90a505e
Route
TOPICAL
Published
Effective Date 2019-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (17.5 ug)
Inactive Ingredients
Octenylsuccinic Acid Carthamus Tinctorius (safflower) Oleosomes Levomenol Glyceryl Monostearate Edetate Disodium Kukui Nut Oil Stearic Acid Cetyl Alcohol Ginger Calcium Pantothenate Pyridoxine Hydrochloride Arginine Aspartic Acid Proline Serine Alanine Glycerin Peg-100 Stearate Carthamus Tinctorius Flower Oil Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Butylene Glycol Hyaluronate Sodium Water Niacinamide .alpha.-tocopherol Acetate Valine Isoleucine Phenylalanine Phenoxyethanol Caprylyl Glycol Maltodextrin Lysine Histidine Glutamic Acid Glycine Leucine Aloe Vera Leaf Silicon Dioxide Sodium Ascorbyl Phosphate Tyrosine Chlorphenesin Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-04 Until 2022-01-01

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

beneficial for face, hands, body and legs

Dosage and Administration

Directions

Apply cream liberally as needed

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

Alanine, Aleurites Moluccanus (Kukui) Seed Oil, Aloe

Barbadensis Leaf Juice, Arginine, Aspartic Acid, Bisabolol,

Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl

Glycol, Carthamus Tinctorius (Safflower) Oleosomes,

Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol,

Chlorphenesin, Dimethicone Crosspolymer, Dimethicone,

Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl

Stearate, Glycine, Histidine, Isoleucine, Leucine, Lysine,

Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate,

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), Triethanolamine, Tyrosine, Valine, Water, Zingiber

Officinale (Ginger) Root Extract

Section 51945-4



NDC 68599-0218-4

McKesson

Thera

MOISTURIZING BODY CREAM

Everyday moisturizer and skin conditioner.

Single Patient Use

NET CONTENTS 4 fl oz (118 mL)

MFR # 53-CRM4

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

beneficial for face, hands, body and legs

Dosage and Administration (34068-7)

Directions

Apply cream liberally as needed

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

Alanine, Aleurites Moluccanus (Kukui) Seed Oil, Aloe

Barbadensis Leaf Juice, Arginine, Aspartic Acid, Bisabolol,

Butylene Glycol, Calcium Pantothenate (Vitamin B5), Caprylyl

Glycol, Carthamus Tinctorius (Safflower) Oleosomes,

Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol,

Chlorphenesin, Dimethicone Crosspolymer, Dimethicone,

Disodium EDTA, Fragrance, Glutamic Acid, Glycerin, Glyceryl

Stearate, Glycine, Histidine, Isoleucine, Leucine, Lysine,

Maltodextrin, Niacinamide (Vitamin B3), PEG-100 Stearate,

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), Triethanolamine, Tyrosine, Valine, Water, Zingiber

Officinale (Ginger) Root Extract

Section 51945-4 (51945-4)



NDC 68599-0218-4

McKesson

Thera

MOISTURIZING BODY CREAM

Everyday moisturizer and skin conditioner.

Single Patient Use

NET CONTENTS 4 fl oz (118 mL)

MFR # 53-CRM4

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

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