Label: SLMD SILVER SULFUR ACNE CREAM- sulfur cream
- NDC Code(s): 59958-407-01, 59958-407-02
- Packager: Owen Biosciences Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 16, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
-
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 mouthDo not use on:
• broken skin
• large areas of the skinStop 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.
- Sulfur Carton.jpg
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INGREDIENTS AND APPEARANCE
SLMD SILVER SULFUR ACNE CREAM
sulfur creamProduct 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)
