CREAM- salicylic acid lotion 
Oxygen Development 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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ACNE SERUM Medicated Treatment

Active Ingredient

Salicylic Acid

Purpose

Acne Medication

Uses

Treats Acne and helps skin heal. Penetrates pores to eliminate most acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads from forming

Warnings

For external use only

When using use only

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.

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 morning and night for best results.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Store at 20 - 25C (68-77F)

Inactive Ingredient

Water/Aqua, Propanediol, Glycerin, Caprylic/Capric Triglyceride, Dimethyl Isosorbide, Lactobacillus Ferment, Coconut Alkanes, Coco-Caprylate, Niacinamide, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Tranexamic Acid, Hexyl Laurate, Glycine Soja Soybean, C15-19 Alkane, Potassium Azeloyl Diglycinate, Hydrogenated Polydecene, Glyceryl Stearate, Ceramide NP, Ceramide AP, Bakuchiol, Fucus Spiralis Extract, Rhodomyrtus Tomentosa Fruit Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Acetyl Glucosamine, Hydrolyzed Sodium Hyaluronate, Zinc Sulfate, Melia Azadirachta Leaf Extract, Centella Asiatica Leaf Extract, Silybum Marianum Seed Extract, Vitex Agnus - Castus Extra, Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Allantoin, Panthenol, 1,2 - Hexanediol, Sodium Stearoyl Lactylate, Citric Acid, Xanthan Gum, Polyglyceryl - 3 Diisostearate, Polyacrylate Crosspolymer - 6, Coco - Caprylate/Caprate, Caprylhydroxamic Acid, Sodium Phytate, Tocopherol, Sodium Benzoate, Potassium Sorbate, Biosaccaharide Gum - 1, Phenoxyethanol, Sodium Anisate.

61354-099_aw

61354-099-01_aw

CREAM 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
NIACINAMIDE (UNII: 25X51I8RD4) 3 mg  in 100 mg
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2.5 mg  in 100 mg
C15-19 ALKANE (UNII: CI87N1IM01) 1.2 mg  in 100 mg
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) 4 mg  in 100 mg
COCONUT ALKANES (UNII: 1E5KJY107T) 3.76 mg  in 100 mg
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 5.5 mg  in 100 mg
COCO-CAPRYLATE (UNII: 4828G836N6) 3.5 mg  in 100 mg
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP) 3.97 mg  in 100 mg
TRANEXAMIC ACID (UNII: 6T84R30KC1) 2 mg  in 100 mg
BAKUCHIOL (UNII: OT12HJU3AR) 0.5 mg  in 100 mg
POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP) 1 mg  in 100 mg
GLYCERIN (UNII: PDC6A3C0OX) 6.07 mg  in 100 mg
DOCOSANOL (UNII: 9G1OE216XY) 2.5 mg  in 100 mg
SOYBEAN OIL (UNII: 241ATL177A) 1.3 mg  in 100 mg
1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.75 mg  in 100 mg
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) 0.5 mg  in 100 mg
HEXYL LAURATE (UNII: 4CG9F9W01Q) 1.5 mg  in 100 mg
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 1 mg  in 100 mg
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) 1 mg  in 100 mg
CANDELILLA WAX (UNII: WL0328HX19) 2.5 mg  in 100 mg
WATER (UNII: 059QF0KO0R) 38.78 mg  in 100 mg
PROPANEDIOL (UNII: 5965N8W85T) 7.47 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-099-011 in 1 CARTON06/26/2023
1100 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00606/26/2023
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-099)

Revised: 6/2023
Document Id: ff0b2dc9-c372-4bb6-e053-6394a90aefad
Set id: ff0b2dc9-c371-4bb6-e053-6394a90aefad
Version: 1
Effective Time: 20230626
 
Oxygen Development LLC