OTC Medication Information: Advanced Acne Spot Treatment CVS

ADVANCED ACNE SPOT TREATMENT CVS- salicylic acid lotion
CVS

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.

Active ingredient Purpose

Salicylic Acid – 2.00% Acne Medication

Use

For treatment of acne

Warnings For external use only

​Flammable. Keep away from 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 or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor.

Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water

Directions ​• cleans the skin thoroughly before applying medication • cover the entire affected area with a thin layer one to three times a day • If bothersome dryness or peeling occurs, reduce application to once a day or every other day. • Recomended for daily use.

Inactive ingredients :Water, Alcohol, Hamamelis Virginiana (Witch Hazel) Extract, Glycerin, C13-14 Isoparaffin, Laureth-7, Polyacrylamide
C12-15 Alkyl Lactate, Cetyl Lactate, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Butylene Glycol, Dimethicone, Capryloyl Glycine, Ammonium Hydroxide, Portulaca Oleracea Extract, Benzalkonium Chloride, Propylene Glycol, Cocamidopropyl PG-Dimonium , hloride Phosphate, Cyclopentasiloxane, Phenoxyethanol, Dehydroxanthan Gum, Denatonium Benzoate, Fragrance, Hexylene Glycol, Polysorbate 20, PPG-2 Isoceteth-20 Acetate, Sarcosine, t-Butyl Alcohol, Tetrasodium EDTA

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ADVANCED ACNE SPOT TREATMENT CVS
salicylic acid 2.00% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-343
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (SALICYLIC ACID) Salicylic Acid 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Alcohol
HAMAMELIS VIRGINIANA TOP WATER
Glycerin
C13-14 Isoparaffin
Laureth-7
C12-15 Alkyl Lactate
Cetyl Lactate
CEDRUS ATLANTICA BARK
CINNAMON BARK OIL
Butylene Glycol
Capryloyl Glycine
AMMONIA
PURSLANE
Benzalkonium Chloride
Propylene Glycol
CYCLOMETHICONE 5
Phenoxyethanol
Dehydroxanthan Gum
Denatonium Benzoate
Polysorbate 20
PPG-2 Isoceteth-20 Acetate
Sarcosine
TERT-BUTYL ALCOHOL
EDETATE SODIUM
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-343-01 1 TUBE in 1 CARTON contains a TUBE
1 22 mL in 1 TUBE This package is contained within the CARTON (59779-343-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 12/22/2014
Labeler — CVS (062312574)
Registrant — Product Quest Mfg. (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg. 927768135 manufacture (59779-343), label (59779-343)

Revised: 12/2017 CVS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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