CREAM- salicylic acid stick 
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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LIFE BRAND CLEAR ACTION ACNE TREATMENT CONCEALER STICK SALICYLIC ACID ACNE MEDICATION

Directions

Cleanse skin thoroughly with non-medicated cleanser before applying medication. Apply a thin layer to desired area and gently pat until concealer is blended in. For best results, apply under make-up. Apply 1-3 times daily. If excessive dryness occurs, reduce daily applications, or use as directed by your physician.

Warning

For external use only. Use only on non-complex facial acne. Avoid contact with eyes. If contact occurs, immediately flush with water. Do not use with another acne medication, except on the advice of a doctor. If excessive skin irritation develops or increases discontinue use; if irritation persists, consult a doctor.

Medicinal Ingredient

Salicylic Acid 2% w/w

Non-Medicinal Ingredients

Octyldodecyl Neopentanoate, Octyldodecanol, Kaolin, Ozokerite, Dipropylene Glycol, Avena Sativa (Oat) Kernel Oil, Hydrogenated Castor Oil, Cetyl Alcohol, Paraffin, Triethoxycaprylylsilane, Phenoxyethanol, Propylparaben, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben. May Contain: Titanium Dioxide, Iron Oxides.

Keep out of reach of children.

Keep out of reach of children.

Anti-Acne

Use the concealer to help combat existing pimples or prevent new ones from developing.

Secondary Packaging (Blister)

61354-060-01_AW61354-060-01_AW

CREAM 
salicylic acid stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
CERESIN (UNII: Q1LS2UJO3A)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
KAOLIN (UNII: 24H4NWX5CO)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-060-011 in 1 BLISTER PACK02/23/2021
11.9 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/23/2021
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492api manufacture(61354-060)

Revised: 2/2021
Document Id: bc017b67-de4d-4f0f-e053-2a95a90aa5b6
Set id: bc017b67-de4e-4f0f-e053-2a95a90aa5b6
Version: 1
Effective Time: 20210223
 
Oxygen Development LLC