SPL v2
SPL
SPL Set ID f2274f8c-08aa-eb02-e053-2a95a90a3998
Route
TOPICAL
Published
Effective Date 2023-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aloe Vera Leaf (0.042 g) Linalool, (+/-)- (0.012 g) Eugenol (5.988 g) Propanediol (0.0018 g) Benzyl Alcohol (0.054 g) Cetostearyl Alcohol (0.0006 g) Dicaprylyl Ether (2.496 g) Sorbic Acid (0.456 g) Xanthan Gum (1.2 g) .beta.-citronellol, (r)- (1.5 g) Glyceryl Monostearate (0.024 g) Fragrance 13576 (0.18 g) Salicylic Acid (2.4 g) Jujube Seed (0.114 g) Lecithin, Soybean (0.09 g) Baicalin (0.048 g) Leuzea Carthamoides Root (0.036 g) Water (33.2616 mL) Limonene, (+)- (0.006 g) Hydroxycitronellal (0.0024 g) Tocopherol (3.036 g) Glycerin (3.9 g) Decyl Oleate (3 g) Shea Butter (2.1 g)
Inactive Ingredients
Sodium Hydroxide Potassium Sorbate Citric Acid Monohydrate Phytate Sodium Hydrogenated Palm Glycerides Citrate Deanol Sodium Benzoate Hyaluronate Sodium Glyceryl Stearate Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-01-13 Until 2028-03-06


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)