SPL v2
SPL
SPL Set ID eac771e2-4c1b-3808-e053-2995a90ac5fc
Route
TOPICAL
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.05 g) Aloe Vera Leaf (2.5 g) Fragrance 13576 (0.225 g) Glyceryl Monostearate (0.875 g) Trolamine (0.3 g) Butylated Hydroxytoluene (0.0535 g) Propylene Glycol (0.1463 g) Cetyl Alcohol (1.996 g) Tropolone (0.0038 g) Tocopherol (0.004 g) Dimethicone (0.0004 g) 1,2-hexanediol (0.25 g) Imidurea (0.198 g) Carbomer Homopolymer, Unspecified Type (0.15 g) Cetearyl Ethylhexanoate (1.75 g) Medium-chain Triglycerides (1.5 g) Caprylyl Glycol (3.4965 g) Octinoxate (0.4975 g) Glycerin (0.1 g) Glyceryl Stearate Se (27.4065 mL) Water (2.25 g) C12-20 Acid Peg-8 Ester (2 g) Oxybenzone (1.9996 g) Decyl Oleate
Inactive Ingredients
Cetyl Phosphate Sodium Chondroitin Sulfate (porcine; 5500 Mw) Hyaluronate Sodium .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-17 Until 2028-01-16


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)