SPL v1
SPL
SPL Set ID 2f3f2a14-d030-12e7-e063-6294a90ab889
Route
EXTRACORPOREAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Morinda Citrifolia Fruit (2 g) Allantoin (5 mL) Melia Azadirachta Leaf (0.1 mL) Adenosine (0.5 mL)
Inactive Ingredients
Glycerin Butylene Glycol Propylene Glycol Sucrose Palmitate Cocoa Simmondsia Chinensis (jojoba) Seed Oil Dipropylene Glycol Diethoxyethyl Succinate Glyceryl Polymethacrylate (300000 Mpa.s) Vitis Vinifera (grape) Seed Oil Tocopherol Cetearyl Olivate Sodium Hyaluronate Ethylhexylglycerin Octyldodeceth-16 1,2-hexanediol Sodium Polyacryloyldimethyl Taurate Magnesium Disodium Edta Sorbitan Olivate Panthenol Rosmarinus Officinalis (rosemary) Leaf Oil Macadamia Integrifolia Seed Oil Aqua

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-10

Description

Net Wt. 1FL. OZ (30 ml)


Medication Information

Warnings and Precautions

1.For External Use Only. 2.Avoid Direct Contact with Eyes. 3.If the product gets into your eyes, rinse immediately with plenty of water. 4.Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist. 5.Do Not Apply on Broken or Irritated Skin. Keep Out of Reach of Children.

Indications and Usage

Step 1: Use daily, AM and PM.

Step 2: Cleanse skin to remove impurities.

Step 3: Apply appropriate amount post - cleansing.

Step 4: Use before heavy moisturizers or oils for better absorption.

Dosage and Administration

Net Wt. 1FL. OZ (30 ml)

Description

Net Wt. 1FL. OZ (30 ml)

Section 50565-1

Keep Out of Reach of Children.

Section 51945-4

Section 55105-1

MOISTURIZES & SOOTHES & RADIANCE


Structured Label Content

Indications and Usage (34067-9)

Step 1: Use daily, AM and PM.

Step 2: Cleanse skin to remove impurities.

Step 3: Apply appropriate amount post - cleansing.

Step 4: Use before heavy moisturizers or oils for better absorption.

Dosage and Administration (34068-7)

Net Wt. 1FL. OZ (30 ml)

Warnings and Precautions (34071-1)

1.For External Use Only. 2.Avoid Direct Contact with Eyes. 3.If the product gets into your eyes, rinse immediately with plenty of water. 4.Discontinue Use if Irritation Occurs: If redness, itching, or irritation develops, stop use and consult a dermatologist. 5.Do Not Apply on Broken or Irritated Skin. Keep Out of Reach of Children.

Section 50565-1 (50565-1)

Keep Out of Reach of Children.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

MOISTURIZES & SOOTHES & RADIANCE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)