THERESIENOL MD SKIN PROTECTANT- lanolin liquid

Theresienol MD Skin Protectant by

Drug Labeling and Warnings

Theresienol MD Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Fordee Group, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Lanolin 12.5%

PURPOSE

Purpose

Skin protectant

INDICATIONS & USAGE

Uses temporarily protects

• minor cuts, scrapes and burns
• chafed, chapped or cracked skin

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

WHEN USING

When using this product do not get into eyes

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again in a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions apply as needed

STORAGE AND HANDLING

Other information

• store between 46°-77°F (8°-25°C)
• use within 6 months of opening

INACTIVE INGREDIENT

Inactive ingredients

Apple Fruit Extract, Chicken Fat Extract, Clarified Butter, Pentylene Glycol, Sea Onion Leaf Extract, Tocopherol, Tocopherol Acetate

SPL UNCLASSIFIED SECTION

Multi-purpose natural skin care serum with lanolin for all skin types, all ages & all stages.

Works naturally with your body.

• Protects and helps relieve minor burns
• Protects and helps relieve minor scrapes
• Helps relieve & heals cracked or chapped skin
• Soothes, hydrates & protects irritated skin
• Natural ingredients

Exclusively distributed by:

4DG

1700 Post Oak Blvd.

2BLVD PLACE, Suite 600

Houston, TX 77056, USA

www.4DG.life

Made in Austria

SPL UNCLASSIFIED SECTION

Skin protectant drug product.

A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.

PRINCIPAL DISPLAY PANEL

Theresienol MD

Multi-purpose

SKIN PROTECTANT+ with LANOLIN

for minor

BURNS+CUTS+SCRAPES

NATURAL SKIN SERUM

0.5 fl. oz. / 15ml

INGREDIENTS AND APPEARANCE

THERESIENOL MD SKIN PROTECTANT 
lanolin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72184-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	12.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALBUCA BRACTEATA WHOLE (UNII: GK156DX76Z)
BUTTER (UNII: 3B7C0987O9)
CHICKEN FAT (UNII: A2OSN87060)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TOCOPHEROL (UNII: R0ZB2556P8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
APPLE FRUIT OIL (UNII: 9NT987I3A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72184-001-15	1 in 1 CARTON	03/26/2018
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72184-001-04	1 in 1 CARTON	03/26/2018
2		40 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 72184-001-20	1 in 1 CARTON	03/26/2018
3		200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
4	NDC: 72184-001-01	10 in 1 CARTON	03/26/2018
4		1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/26/2018

Labeler - Fordee Group, LLC (081100199)