SPL v1
SPL
SPL Set ID cb68bec5-9e54-1664-e053-2995a90a5eab
Route
TOPICAL
Published
Effective Date 2021-09-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1 U)
Inactive Ingredients
Lactic Acid Polysorbate 20 Sodium Benzoate Water Decyl Glucoside Cocamidopropyl Betaine Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Allantoin Sodium Levulinate Sodium Anisate Potassium Sorbate Melaleuca Alternifolia Leaf Maltooligosyl Glucoside Hydrogenated Starch Hydrolysate Peg-6 Caprylic/capric Glycerides Matricaria Chamomilla Flowering Top Calendula Officinalis Flower Cucumis Sativus Leaf Methylpropanediol Sodium Cocoamphoacetate Propylene Glycol Dicaprylate/dicaprate Rosa Multiflora Fruit Sodium Chloride Laureth-2 Phenylpropanol Lauryl Glucoside Peg-90 Glyceryl Isostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-09-07

Description

ACTIVE INGREDIENT

Indications and Usage

indications and usage

Purpose

PURPOSE AND USES


Medication Information

Warnings and Precautions

WARNINGS

Indications and Usage

indications and usage

Purpose

PURPOSE AND USES

Description

ACTIVE INGREDIENT

Dosage

dosage

Keep Out

KEEP OUT

Pregnancy

PREGNANCY WARNING

Questions

QUESTIONS

Ask Doctor

ASK DOCTOR

Indications

indications

Active Ingredient

ACTIVE INGREDIENT

Inactive Ingredients

inactive ingredients

Principal Display Panel

PRINCIPAL DISPLAY PANEL

Warnings and Precaution

WARNINGS AND PRECAUTION


Structured Label Content

Dosage (dosage)

dosage

Warnings and Precautions (34071-1)

WARNINGS

Purpose (PURPOSE)

PURPOSE AND USES

Keep Out (KEEP OUT)

KEEP OUT

Pregnancy (PREGNANCY)

PREGNANCY WARNING

Questions (QUESTIONS)

QUESTIONS

Ask Doctor (ASK DOCTOR)

ASK DOCTOR

Indications (indications)

indications

Active Ingredient (ACTIVE INGREDIENT)

ACTIVE INGREDIENT

Inactive Ingredients (inactive ingredients)

inactive ingredients

Indications and Usage (indications and usage)

indications and usage

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PRINCIPAL DISPLAY PANEL

Warnings and Precaution (WARNINGS AND PRECAUTION)

WARNINGS AND PRECAUTION


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)