LACTO-S ACNE TREATMENT- salicylic acid cream

LACTO-S by

Drug Labeling and Warnings

LACTO-S by is a Otc medication manufactured, distributed, or labeled by Noon Aesthetics M.R. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Uses

• Use for the treatment 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.

Keep out of reach of children.

• If swallowed, get help or contact a Poison Control Center right away.

Directions

• Cleanse 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, if needed or as directed by a doctor. 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 of peeling occurs, reduce application to one a day or every other day.

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), Lactic Acid, Propanediol, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polyacrylate Crosspolymer-6, Isononyl Isononanoate, Ethylhexyl Stearate, Citronellyl Methylcrotonate, Polysorbate 20, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Wheat Straw Glycosides, Cetearyl Alcohol, Cyclopentasiloxane, Dimethicone, T-Butyl Alcohol, Sodium Phytate, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Parfum, Sodium Hydroxide, Alcohol, Limonene.

SPL UNCLASSIFIED SECTION

Developed + Dist by
noon
AESTHETICS
TLV, 62153 | Made in Israel
noonaesthetics.com

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

no
on
AESTHETICS

Lacto-S
ACNE TREATMENT

+ DERMSHIELD™

NDC: 78863-3001-2

50 mL / 1.75 Fl. Oz. ℮

INGREDIENTS AND APPEARANCE

LACTO-S   ACNE TREATMENT
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78863-3001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CITRONELLYL METHYLCROTONATE (UNII: K61O222P3D)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL WHEAT STRAW GLYCOSIDES (UNII: B44PS4T8IN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
PHYTATE PERSODIUM (UNII: 3F6PM8J684)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FRAGRANCE 13576 (UNII: 5EM498GW35)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
LIMONENE, (+/-)- (UNII: 9MC3I34447)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78863-3001-2	1 in 1 CARTON	06/10/2024
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 78863-3001-1	1 in 1 CARTON	06/10/2024
2		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 78863-3001-3	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	06/10/2024

Labeler - Noon Aesthetics M.R. Ltd (600185560)

Establishment
Name	Address	ID/FEI	Business Operations
Noon Aesthetics M.R. Ltd		600185560	MANUFACTURE(78863-3001)