074 078 Remedy Phytoplex Barrier Cream Cloths

074 078 Remedy Phytoplex Barrier Cream Cloths
SPL v11
SPL
SPL Set ID 00e0cd4a-6049-408a-ab3f-9edf97e6438a
Route
TOPICAL
Published
Effective Date 2022-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (3.6 g)
Inactive Ingredients
Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Water Glycerin Soybean Oil Clove Shea Butter Lecithin, Soybean Allantoin C12-20 Alkyl Glucoside C14-22 Alcohols Cetyl Alcohol Disodium Cocoamphodiacetate Medium-chain Triglycerides Citric Acid Monohydrate Coco Glucoside Coconut Alcohol Ethylene Brassylate Ethylhexylglycerin Butylene Glycol Isopropyl Myristate Methyl Dihydrojasmonate (synthetic) Yeast Phenoxyethanol .alpha.-tocopherol Acetate Urea 7-dehydrocholesterol Sunflower Oil Corn Oil Vanilla Green Tea Leaf Polysorbate 60 Isohexadecane Phymatolithon Calcareum Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-31 Until 2025-07-31
Description

Dimethicone 3.6% w/w

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Dimethicone 3.6% w/w

Uses
  • helps protect from minor skin irritations associated with perineal dermatitis
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Warnings

For external use only

Directions
  • Open package as designated
  • Remove fresh cloths and thoroughly cleanse soiled area as needed
  • Dispose of cloths in waste receptacle, do not flush in toilet
  • Single Patient Use only
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient

Dimethicone 3.6% w/w

Other Information
  • Protect from freezing, avoid excessive heat
  • Keep label tightly sealed
  • Do Not Flush
  • Cloth: made of Rayon/Polyester
Inactive Ingredients

algae extract, allantoin, butylene glycol,

butyrospermum parkii (shea butter) extract,

C12-20 alkyl glucoside, C14-22 alcohols,

camellia sinensis (green tea) extract,

caprylic/capric triglyceride, cetyl alcohol,

citric acid, cocoglucoside, coconut alcohol,

7- dehydrocholesterol, disodium

cocoamphodiacetate, ethylene brassylate,

ethylhexylglycerin, eugenia caryophyllus

(clove) flower extract, glycerin, glycine soja

(soybean) oil, helianthus annuus

(sunflower) seed oil, hydrolyzed soy

protein, hydroxyethyl acrylate/sodium

acryloyldimethyltaurate copolymer,

isohexadecane, isopropyl myristate,

lecithin, methyldihydrojasmonate,

phenoxyethanol, phospholipids,

polysorbate 60, tocopheryl acetate, urea,

vanilla plantifolia fruit extract, water, 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 with domestic and imported materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092508, MSC092507

V2 RE22MSC, V2 RF22MSC

Stop Use and Ask A Doctor
  • condition worsens
  • symptoms last 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 protect from minor skin irritations associated with perineal dermatitis
  • temporarily protects and helps relieve chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Purpose

Skin Protectant

Warnings

For external use only

Directions
  • Open package as designated
  • Remove fresh cloths and thoroughly cleanse soiled area as needed
  • Dispose of cloths in waste receptacle, do not flush in toilet
  • Single Patient Use only
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient (Active ingredient)

Dimethicone 3.6% w/w

Other Information (Other information)
  • Protect from freezing, avoid excessive heat
  • Keep label tightly sealed
  • Do Not Flush
  • Cloth: made of Rayon/Polyester
Inactive Ingredients (Inactive ingredients)

algae extract, allantoin, butylene glycol,

butyrospermum parkii (shea butter) extract,

C12-20 alkyl glucoside, C14-22 alcohols,

camellia sinensis (green tea) extract,

caprylic/capric triglyceride, cetyl alcohol,

citric acid, cocoglucoside, coconut alcohol,

7- dehydrocholesterol, disodium

cocoamphodiacetate, ethylene brassylate,

ethylhexylglycerin, eugenia caryophyllus

(clove) flower extract, glycerin, glycine soja

(soybean) oil, helianthus annuus

(sunflower) seed oil, hydrolyzed soy

protein, hydroxyethyl acrylate/sodium

acryloyldimethyltaurate copolymer,

isohexadecane, isopropyl myristate,

lecithin, methyldihydrojasmonate,

phenoxyethanol, phospholipids,

polysorbate 60, tocopheryl acetate, urea,

vanilla plantifolia fruit extract, water, 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 with domestic and imported materials

www.medline.com

1-800-MEDLINE (633-5463)

REF: MSC092508, MSC092507

V2 RE22MSC, V2 RF22MSC

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • condition worsens
  • symptoms last 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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.456764 · Updated: 2026-03-14T23:02:25.522673