Label: ACNE SERUM- skin restoring acne serum gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61531-101-01 - Packager: Universal Packaging Systems, Inc. DBA: Paklab
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 26, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WARNINGS AND PRECAUTIONS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
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INACTIVE INGREDIENT
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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE SERUM
skin restoring acne serum gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61531-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color yellow (pinkish to yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61531-101-01 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/26/2015 Labeler - Universal Packaging Systems, Inc. DBA: Paklab (790530976)