159 Remedy Specialized Silicone Cream

159 Remedy Specialized Silicone Cream
SPL v3
SPL
SPL Set ID ddab5235-1188-3866-e053-2a95a90a7a31
Route
TOPICAL
Published
Effective Date 2023-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (125 mg)
Inactive Ingredients
Dimethiconol (2000 Cst) Jojoba Oil, Randomized Phenoxyethanol Medium-chain Triglycerides Cholecalciferol Clove Hexyldecanol Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Aphanizomenon Flosaquae Carthamus Tinctorius (safflower) Oleosomes Glycerin Olive Oil Honey Cetylhydroxyproline Palmitamide Peg/ppg-18/18 Dimethicone Phytonadione Propanediol Stearic Acid Alpha-tocopherol Acetate Yeast, Unspecified Corn Oil Water Sodium Chloride Omega-3 Fatty Acids Levomenol Rapeseed Sterol Green Tea Leaf 7-dehydrocholesterol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

Dimethicone 12.5% w/v

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 12.5% w/v

Uses
  • helps treat and prevent diaper rash
  • protects minor skin irritation with diaper rash and helps seal out wetness
Warnings

For external use only

Directions
  • change wet and soiled diapers promptly, cleans the diaper area and allow to dry
  • apply cream liberally as often as necessary with each diaper change esspecially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient

Dimethicone 12.5% w/v

Other Information
  • protect from freezing, avoid excessive heat
Inactive Ingredients

7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, dimethicone crosspolymer, dimethiconol, divinyldimethicone/dimethicone copolymer emulsion, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, jojoba esters, lauryl PEG-10 tris (trimethylsiloxy) silylethyl dimethicone, manuka honey, olea europaea (olive) oil, PEG/PPG-18/18 dimethicone, phenoxyethanol, phospholipids, phytonadione, propanediol, purified water, sodium chloride, stearic acid, tocopheryl acetate, yeast ferment extract, zea mays (corn) oil.

When Using This Product
  • do not get into eyes
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of domestic and imported materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092564

V3 RJ23BLB

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects minor skin irritation with diaper rash and helps seal out wetness
Purpose

Skin protectant

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly, cleans the diaper area and allow to dry
  • apply cream liberally as often as necessary with each diaper change esspecially at bedtime or anytime when exposure to wet diapers may be prolonged
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient (Active ingredient)

Dimethicone 12.5% w/v

Other Information (Other information)
  • protect from freezing, avoid excessive heat
Inactive Ingredients (Inactive ingredients)

7-dehydrocholestrol, aphanizomenon flos-aquae (algae) extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, dimethicone crosspolymer, dimethiconol, divinyldimethicone/dimethicone copolymer emulsion, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, jojoba esters, lauryl PEG-10 tris (trimethylsiloxy) silylethyl dimethicone, manuka honey, olea europaea (olive) oil, PEG/PPG-18/18 dimethicone, phenoxyethanol, phospholipids, phytonadione, propanediol, purified water, sodium chloride, stearic acid, tocopheryl acetate, yeast ferment extract, zea mays (corn) oil.

When Using This Product (When using this product)
  • do not get into eyes
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of domestic and imported materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092564

V3 RJ23BLB

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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