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
Purpose

Skin protectant

Description

Dimethicone 12.5% w/v

Medication Information

Warnings

For external use only

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

Skin protectant

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
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.

Description

Dimethicone 12.5% w/v

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient

Dimethicone 12.5% w/v

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

Warnings

For external use only

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

Skin protectant

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
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.

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

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:04.927667 · Updated: 2026-03-14T23:02:57.214195