Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 4fa7bd2b-04c4-4d86-9e5f-e70e6020e5b8
Route
TOPICAL
Published
Effective Date 2012-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1 g)
Inactive Ingredients
Aloe Vera Leaf Butylene Glycol Cetearyl Ethylhexanoate Edetate Disodium Glycerin Isostearic Acid Methylparaben Phenoxyethanol Polysorbate 20 Propylene Glycol Propylparaben Povidone Sorbitol Spirulina Platensis Stearic Acid Alpha-tocopherol Acetate Trolamine Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-07-15
Description

Active Ingredient Dimethicone 1%

Medication Information

Warnings and Precautions

Warnings ■ Do not use on children 2 years of age unless directed by a doctor ■ For external use only ■ Avoid spraying into the eyes ■ Do not use on deep wounds, infections or lacerations ■ Supervise children in the use of this product

Indications and Usage

Uses: Footlogix Moisturizing Diabetic Formula- with Dermal Infusion Technology is an effective daily maintenance formula that hydrates and relieves the extremely dry, cracked skin of the feet. This unique fragrance-free, lightweight mousse formula also softens, protects the skni and prevents damage due to dryness by replenishing the skin's moisture barrier.

Dosage and Administration
Directions ■ Clean the affected area and dry thoroughly ■ Hold the can upright ■ Shake well before each use ■ Use sparingly twice daily for the first two weeks and continue once daily until the problem is corrected  ■ When used as directed, this can contains enough mousse for approximately two months supply ■ If condition persists, consult a doctor
Description

Active Ingredient Dimethicone 1%

Section 42229-5

Caution : ■  Contents are under pressure ■  Protect from direct sunlight and do not store at temperatures above 120F/50C ■  After use, do not puncture or incinerate container ■  Spray only in a well ventilated area ■  Do not spray in presence of open flame or spark or while smoking

Section 50565-1

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Section 50569-3

Stop use and ask a doctor if : ■ irritation occurs or if there is no improvement within 4 weeks ■ there are deep puncture wounds, infections or lacerations

Section 51727-6

I n active Ingredients Aloe Barbadensis Leaf Juice, Butylene Glycol, Cetearyl Ethylhexanoate, Disodium EDTA, Glycerin, Isostearic Acid, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, SD Alcohol 40-B, Sorbitol, Spirulina Platensis Extract, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

Section 51945-4
Product Label



Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active Ingredient

Dimethicone 1%

Structured Label Content

Indications and Usage (34067-9)

Uses: Footlogix Moisturizing Diabetic Formula- with Dermal Infusion Technology is an effective daily maintenance formula that hydrates and relieves the extremely dry, cracked skin of the feet. This unique fragrance-free, lightweight mousse formula also softens, protects the skni and prevents damage due to dryness by replenishing the skin's moisture barrier.

Dosage and Administration (34068-7)
Directions ■ Clean the affected area and dry thoroughly ■ Hold the can upright ■ Shake well before each use ■ Use sparingly twice daily for the first two weeks and continue once daily until the problem is corrected  ■ When used as directed, this can contains enough mousse for approximately two months supply ■ If condition persists, consult a doctor
Warnings and Precautions (34071-1)

Warnings ■ Do not use on children 2 years of age unless directed by a doctor ■ For external use only ■ Avoid spraying into the eyes ■ Do not use on deep wounds, infections or lacerations ■ Supervise children in the use of this product

Section 42229-5 (42229-5)

Caution : ■  Contents are under pressure ■  Protect from direct sunlight and do not store at temperatures above 120F/50C ■  After use, do not puncture or incinerate container ■  Spray only in a well ventilated area ■  Do not spray in presence of open flame or spark or while smoking

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Section 50569-3 (50569-3)

Stop use and ask a doctor if : ■ irritation occurs or if there is no improvement within 4 weeks ■ there are deep puncture wounds, infections or lacerations

Section 51727-6 (51727-6)

I n active Ingredients Aloe Barbadensis Leaf Juice, Butylene Glycol, Cetearyl Ethylhexanoate, Disodium EDTA, Glycerin, Isostearic Acid, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, PVP, SD Alcohol 40-B, Sorbitol, Spirulina Platensis Extract, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Urea, Water.

Section 51945-4 (51945-4)
Product Label



Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active Ingredient

Dimethicone 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.780313 · Updated: 2026-03-14T22:53:14.066899