SLMD SILVER SULFUR ACNE CREAM- sulfur cream

SLMD Silver Sulfur Acne Cream by

Drug Labeling and Warnings

SLMD Silver Sulfur Acne Cream by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

     Sulfur 3.0%

Purpose

Acne Treatment 

Use

Use for the management of acne

WarningsFor external use only.

When using this product:
skin irritation and dryness is
more likely to occur if you use
another topical acne medication
at the same time. If irritation
occurs, only use one topical
acne medication at a time.
apply only to areas with acne
avoid contact with the eyes, lips, and mouth

Do not use on:
broken skin
large areas of the skin

Stop use and ask a doctor if
irriatation becomes servere.

Keep out of reach of children.
If swallowed, get medical help or
contact a Poison Control Center
right away

Directions

clean the skin thoroughly before
applying this product
cover the entire affected area with
a thin layer one to three times
daily because excessive drying
of the skin may occur, start with
one applicagtion daily, then
gradually increase to two or three
times daily if needed or as
directed by a doctor
if bothersome dryness or peeling
occurs, reduce application to
once a day or every other day
Sensitivity Test for a New User:
Apply product sparingly to one or
two small affected areas during
the first 3 days. If no discomfort
occurs, follow the directions
stated above.

INACTIVE INGREDIENT

Water (aqua), Tromethamine,
C12-15 Alkyl Benzoate, Butylene
Glycol, Prunus Amygdalus Dulcis
(Sweet Almond) Oil, Ethylhexyl
Isononanoate, Glycerin,
Polyglyceryl-3 Methylglucose
Distearate, Cetearyl Alcohol,
Cetyl Dimethicone, Myristyl
Myristate, Cyclopentasiloxane,
Cydotetrasiloxane, Dimethiconol,
Phenoxyethanol, Ethylhexylgly-
gercin, Hydroxyethyl Acrylate/
Sodium Acryloyldimethyl Taurate
Copolymer, Squalane, Polysorbate
60, p-Anisic Acid, Xanthan Gum,
Myristoyl Tetrapeptide-13, Colloidal
Silver Solution

Keep out of reach of children.

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

Sulfur Carton.jpg

Sulfur Carton.jpg

INGREDIENTS AND APPEARANCE

SLMD SILVER SULFUR ACNE CREAM 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-407
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	71.69 g  in 100 g
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	3 g  in 100 g
ALMOND OIL (UNII: 66YXD4DKO9)	3 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-407-02	1 in 1 CARTON	08/30/2019
1	NDC: 59958-407-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/30/2019

Labeler - Owen Biosciences Inc. (790003045)

Registrant - Owen Biosciences Inc. (790003045)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences Inc.		790003045	manufacture(59958-407)