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SPL v2

SPL

SPL Set ID 23a2a04f-71ce-4fa1-e063-6394a90a649e

Route

TOPICAL

Published

Effective Date 2025-04-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Dimethicone 100 (5 g)

Inactive Ingredients

Dicaprylyl Carbonate Glyceryl Stearate Se Sodium Citrate Caprylic/capric Triglyceride Sodium Benzoate Steareth-20 Sodium Gluconate Glycerin Ceteth-20 Sorbitan Caprylate Anhydrous Citric Acid Phenoxyethanol Jojoba Oil, Randomized Water Helianthus Annuus (sunflower) Seed Wax Ethylhexylglycerin Xanthan Gum Cetyl Alcohol Peg-8 Beeswax .alpha.-tocopherol, D- Acacia Decurrens Flower Wax Polyglycerin-3 Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-04-22

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:58.672524 · Updated: 2026-03-14T23:08:25.015175