SENOPHILE DERMAL- petrolatum, cod liver ointment

Senophile Dermal by

Drug Labeling and Warnings

Senophile Dermal by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Petrolatum 30.00%

Cod Liver Oil 10.00%

Purpose:

Skin Protectant

Skin Protectant

Uses:

• Temporarily protects minor cuts, scrapes, burns
• Temporarily protects chapped or cracked skin.
• Helps protect from the drying effects of wind and cold weather.

Warnings

For external use only;

When using this product,

do not get into eyes.

STOP USE

If condition worsens or does not improve for seven days, discontinue use and consult a physician.

DO NOT USE

DO NOT USE IF TAMPER EVIDENT SEAL IS BROKEN.

Keep out of reach of children.

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

Directions

Apply as needed. Prepare a gauze bandage to apply. Dressing should be placed on a clean and flat surface. Apply ointment with a spatula, covering the entire surface with a thin layer. Place bandage directly on top of affected area. Make sure affected area remains covered by ointment.

Inactive ingredients

Beeswax, BHT, Helianthus Annuus (Sunflower) Oil, Prunus Amygdalus Dulcis (sweet almond) Oil.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY:

Pure Source, Inc.

9750N.W 17th Stre et, Miami, Flo ri da 33.172 - USA

IMPORTED BY:

Laboratór io D audt Oliveira LTDA.

Rua Simõe s da Mot a, 57 - Rio de Ja neiro - RJ

CNPJ: 33.026.055/0001-20

LICENSED BY:

Rev Pharma Curefini.

US Pate nt Nº 7,357,923

Te chnical r esp onsible: Michele Vieira Esp índola - CRF / RJ 17419

Register ANVISA nº: XXXXXXXXXXX

BRAZILIAN INDUSTRY sac@grupodaudt.com.br

Package Label

Senophile

Dermal Ointment

for cuts & burns

208g

INGREDIENTS AND APPEARANCE

SENOPHILE DERMAL 
petrolatum, cod liver ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	40 g  in 100 g
COD LIVER OIL (UNII: BBL281NWFG) (COD LIVER OIL - UNII:BBL281NWFG)	COD LIVER OIL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALMOND OIL (UNII: 66YXD4DKO9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-208-20	208 g in 1 JAR; Type 0: Not a Combination Product	02/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/24/2014

Labeler - Pure Source, LLC (080354456)