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SALISES FACIAL Moisturizing Acne Treatment Gel 50ml

Dosage form: gel
Ingredients: SALICYLIC ACID 15mg in 1mL
Labeler: Sesderma USA LLC
NDC Code: 16047-0028

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.

SALISES FACIAL Moisturizing Acne Treatment Gel 50ml

Drug Facts

Active Ingredient

Salicylic Acid 1.5%

Purpose

Acne treatment

Uses
  • For the treatment of acne

Warnings

For external use only.

Ask a doctor before use

if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product
  • do not get into eyes
  • skin imitation 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.

Stop use and ask a doctor

if excessive skin irritation develops or increases.

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.
  • before excessive drying of the skin may occur, start with one application 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

Inactive ingredients

Acetyl Dipeptide-1 Cetyl Ester, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Alcohol Denat, Aloe Barbadensis Leaf Juice,
Alpha-Isomethyl Ionone, Ammonium Glycyrrhizate, Biotin, Boswelia Serrata Gum, Butylene Glycol, Butylparaben, Butylphenyl Methylpropional, Caffeine, CI 17200 (D&C Red N 33), Citric Acid, Dipropylene Glycol, Disodium EDTA, D-Limonene, Ethylparaben, Faex, Fragance, Hydroxyethylcellulose, Laureth-3, Lecithin, Linalool, Methylparaben, Niacinamide, Panthenol, PEG/PPG-20/6 Dimethicone, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, Sodium Cholate, Sodium Hyaluronate, Trideceth-9, Triethyl Citrate, Water, Yeast Extract, Zinc Gluconate, Zinc PCA.

Product Label

SALISES FACIAL MOISTURIZING ACNE TREATMENT GEL 50ML 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16047-0028
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETYL DIPEPTIDE-1 CETYL ESTER 
HORSE CHESTNUT 
ALOE VERA LEAF 
ISOMETHYL-.ALPHA.-IONONE 
AMMONIUM GLYCYRRHIZATE 
BIOTIN 
BUTYLENE GLYCOL 
BUTYLPARABEN 
BUTYLPHENYL METHYLPROPIONAL 
CAFFEINE 
D&C RED NO. 33 
CITRIC ACID MONOHYDRATE 
DIPROPYLENE GLYCOL 
EDETATE DISODIUM 
LIMONENE, (+)- 
ETHYLPARABEN 
LAURETH-3 
LINALOOL, (+/-)- 
METHYLPARABEN 
NIACINAMIDE 
PANTHENOL 
PEG/PPG-20/6 DIMETHICONE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
PHENOXYETHANOL 
POLYSORBATE 20 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CHOLATE 
HYALURONATE SODIUM 
TRIDECETH-9 
TRIETHYL CITRATE 
WATER 
YEAST, UNSPECIFIED 
ZINC GLUCONATE 
ZINC PIDOLATE 
Packaging
#Item CodePackage Description
1NDC:16047-0028-11 BOTTLE in 1 CARTON
150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/16/2015
Labeler - Sesderma USA LLC (065388108)

Revised: 06/2015
 
Sesderma USA LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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