SLMD SILVER SULFUR ACNE CREAM- sulfur cream 
Owen Biosciences Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SLMD Silver Sulfur Acne Cream -407

Active Ingredient

     Sulfur 3.0%

Purpose

Acne Treatment 

Use

Use for the management of acne

Warnings
For 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.

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

Sulfur Carton.jpg

SLMD SILVER SULFUR ACNE CREAM 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-407
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-407-021 in 1 CARTON08/30/2019
1NDC:59958-407-0150 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D08/30/2019
Labeler - Owen Biosciences Inc. (790003045)
Registrant - Owen Biosciences Inc. (790003045)
Establishment
NameAddressID/FEIBusiness Operations
Owen Biosciences Inc.790003045manufacture(59958-407)

Revised: 1/2023
Document Id: f2679813-2829-ce9e-e053-2995a90a96f8
Set id: 4735a6d6-bf87-404d-a46d-7f29fcff9409
Version: 4
Effective Time: 20230116
 
Owen Biosciences Inc.