SALISES FACIAL MOISTURIZING ACNE TREATMENT GEL- salicylic acid gel
Sesvalia USA LLC

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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SALISES FACIAL Moisturizing acne treatment gel

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 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 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.

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.

■ because 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

Water, sd alcohol, propylene glycol, triethyl citrate, niacinamide, citric acid, hydrozyethylcellulose, butylene glycol, aloe vera (aloe barbadensis) leaf juice, ammonium glycyrrhizate, sodium hyaluronate, zinc gluconate, panthenol, indian frankincense (boswellia serrata) gum, caffeine, biotin, horse chestnut (aesculus hippocastanum) seed extract, faex, acetyl dipeptide-1 cetyl ester, trideceth-9, zinc pca, disodium edta, yeast extract, lecithin, laureth-3, sodium cholate, peg/ppg-20/6 dimethicone, polysorbate 20, dipropylene glycol, butylphenyl methylpropional, peg-40 hydrogenated castor oil, phenoxyethanol, methyl paraben, ethylparaben, propylparaben, butylparaben, alpha-isomethyl ionone, d-limonene, linalool, fragrance, d&c red no. 33

Manufactured by: SESDERMA S.L. Pol. Industrial Rafelbuñol. C/ Massamagrell, 5. 46138 Rafelbuñol.Valencia (Spain) Customer service: 902 100 223. Distributed by: SESVALIA USA LLC. 67 Miracle Mile, Coral Gables, FL 33134 USA. USA Customer service: (1) 800 796 0996. www.sesderma.com Made in SPAIN

SALISES FACIAL Moisturizing acne treatment gel 1.7 fl oz ( 50 ml ) (63181-0016-1)

Inner Packaging SALISES

FACIAL

Moisturizing acne

treatment gel

1.5 % Salicylic acid

1.7 fl oz ( 50 ml )

sesderma

Manufactured by:

SESDERMA S.L. Pol. Industrial Rafelbuñol. C/ Massamagrell, 5. 46138 Rafelbuñol.Valencia (Spain)

Customer service: 902 100 223.

Distributed by:

SESVALIA USA LLC.

67 Miracle Mile, Coral Gables, FL 33134 USA. USA

Customer service: (1) 800 796 0996.

www.sesderma.com

Made in SPAIN

SALISESFacialOuter

SALISES FACIAL MOISTURIZING ACNE TREATMENT GEL
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63181-0016
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
NIACINAMIDE (UNII: 25X51I8RD4)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
PANTHENOL (UNII: WV9CM0O67Z)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
CAFFEINE (UNII: 3G6A5W338E)
BIOTIN (UNII: 6SO6U10H04)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)
TRIDECETH-9 (UNII: X9HD79I514)
EDETATE DISODIUM (UNII: 7FLD91C86K)
YEAST (UNII: 3NY3SM6B8U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LAURETH-3 (UNII: F32E4CB0UJ)
SODIUM CHOLATE (UNII: NU3Y4CCH8Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	white (Viscous hazy colorless to off-white liquid)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63181-0016-1	1 in 1 BOX	04/04/2014	10/31/2015
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	04/04/2014	10/31/2015

Labeler - Sesvalia USA LLC (061096093)

Name	Address	ID/FEI	Business Operations
Establishment
Sesderma S.L.		633606975	manufacture(63181-0016)

Revised: 10/2018

Document Id: 792822c5-3b4f-3edd-e053-2991aa0a9e86

Set id: e18cdf52-b56c-4a86-aa88-ed841665853c

Version: 2

Effective Time: 20181026

Sesvalia USA LLC