SLMD SILVER SULFUR ACNE CREAM- sulfur cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Available from:
Owen Biosciences Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Treatment  Use for the management of acne 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
Authorization status:
OTC monograph final
Authorization number:
59958-407-01, 59958-407-02

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.

----------

Active Ingredient

Sulfur 3.0%

Purpos e

Acne Treatment

Us e

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

SLMD SILVER SULFUR ACNE CREAM

sulfur cream

Owen Biosciences Inc.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 9 58 -40 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

3 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

71.6 9 g in 10 0 g

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

3 g in 10 0 g

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

3 g in 10 0 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 9 58 -40 7-0 2

1 in 1 CARTON

0 8 /30 /20 19

1

NDC:59 9 58 -40 7-0 1

50 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

0 8 /30 /20 19

Labeler -

Owen Biosciences Inc. (790003045)

Registrant -

Owen Biosciences Inc. (790003045)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Owen Bio sciences Inc.

79 0 0 0 30 45

ma nufa c ture (59 9 58 -40 7)

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information