ACNE SERUM- skin restoring acne serum gel 
Universal Packaging Systems, Inc. DBA: Paklab

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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Salicylic Acid 1.0%

Acne medication

for treatment of acne

For external use only

Flammable, keep away from open fire or flame

When using this product and other topical acne medications at the same time or immediately following use of this product, increased dryness of irritation of skin may occur. If this occurs, only one medication should be used unless directed by a doctor

If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Water (Aqua), Alcohol Denat., Glycerin, Salix Nigra (Willow) Bark Extract,Vaccinium Myrtillus Fruit Extract,

Pinus Nigra Bud/Needle Extract, Ribes Nigrum (Black Currant) Fruit Extract, Xanthan Gum, Saccharum Officinarum (Sugar Cane) Extract, Salix Alba (Willow) Bark Extract, Spiraea Ulmaria Flower Extract, Levulinic Acid, Aloe Barbadensis Leaf Juice, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Sodium Levulinate, Citric Acid, Acer Saccharum (Sugar Maple) Extract

Topical gel

Acne Serum componentAcne Serum kit

ACNE SERUM 
skin restoring acne serum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61531-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Coloryellow (pinkish to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61531-101-0130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/26/2015
Labeler - Universal Packaging Systems, Inc. DBA: Paklab (790530976)

Revised: 10/2015
Document Id: 230c795d-a0fb-636e-e054-00144ff8d46c
Set id: 230c795d-a0fa-636e-e054-00144ff8d46c
Version: 1
Effective Time: 20151026
 
Universal Packaging Systems, Inc. DBA: Paklab