SPL v2
SPL
SPL Set ID f22b212d-d21d-5984-e053-2995a90a683e
Route
TOPICAL
Published
Effective Date 2023-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.555 g) Phenoxyethanol (0.243 g) Xanthan Gum (0.15 g) Fragrance 13576 (0.09 g) Sorbitan Isostearate (0.027 g) Hydrolyzed Bovine Elastin (base; 1000 Mw) (0.024 g) Limonene, (+)- (0.006 g) Tocopherol (0.0012 g) Hydroxycitronellal (0.0009 g) Polysorbate 60 (0.0003 g) Lecithin, Soybean (0.0006 g) Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) (0.45 g) Dehydroacetic Acid (0.405 g) Propanediol (0.021 g) Dicaprylyl Ether (0.015 g) Benzoic Acid (1.08 g) Ascorbyl Glucoside (0.9 g) Water (0.036 g)
Inactive Ingredients
Deanol Hyaluronate Sodium Phytate Sodium Citric Acid Monohydrate Sodium Benzoate Sodium Hydroxide Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-01-13 Until 2027-08-05

Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50570-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.305039 · Updated: 2026-03-14T23:01:19.203951