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NDC 69842-0066-01 SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 20 mg/mL Details

SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID 20 mg/mL

SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is SALICYLIC ACID.

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 69842-0066-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	69842-0066
Product ID	69842-066_aca57bce-04c3-47ee-ad55-0c0957e12453
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID
Proprietary Name Suffix	n/a
Non-Proprietary Name	salicylic acid
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	SALICYLIC ACID
Labeler Name	CVS Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0066-01 (69842006601)

Pricing Information	N/A
NDC Package Code	69842-066-01
Billing NDC	69842006601
Package	1 TUBE in 1 CARTON (69842-066-01) / 30 mL in 1 TUBE
Marketing Start Date	2014-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 534cebb1-1c69-44b0-8407-e5863d7eaa31 Details

Active Ingredient

Salicylic Acid 2%

Purpose

Acne treatment

Use

for the management of acne

Warnings

For external use only

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
avoid contact with eyes. If contact occurs, flush thoroughly with water

Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the skin thoroughly before applying this product.
Apply a thin layer to affected area once a day before bedtime.
If bothersome dryness or peeling occurs, reduce application to every other day.
Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated.

Inactive ingredients

Water, Ethoxydiglycol, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, PEG-8, Laureth-4, Dimethicone, Aloe Barbadensis Leaf Juice, Polysorbate 80, DEA-Cetyl Phosphate, Polyacrylamide, Propylene Glycol, Sodium Citrate, Bisabolol, C13-14 Isoparaffin, Xanthan Gum, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben

Microsponge® is a registered trademark of AMCOL International Corp.

Save carton for complete labeling since all warnings are not included on the inner package.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com® 1-800-SHOP CVS

Made in the U.S.A. of U.S. and foreign components

CVS® Quality

Money Back Guarantee

V-13649

PLEASE RECYCLE

V-31490

#987593

FP409

M050790

Principal Display Panel - Carbon Label

SKIN+

PHARMACY

ADVANCED

ACNE

THERAPY

OVERNIGHT

SALICYLIC

ACID

LOTION

with Microsponge®

Technology

Maximum Strength 2% Salicylic Acid

works overnight to help eliminate existing blemishes
helps prevent new breakouts from forming
contains anti-inflammatory Bisabolol & soothing Ale Vera to calm skin
fragrance- & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

Actual Size Product

on Side Panel

1 FL OZ (30 mL)

Principal Display Panel - Tube Label

SKIN+PHARMACY

ADVANCED

ACNE

THERAPY

OVERNIGHT

SALICYLIC ACID LOTION

with Microsponge® Technology

Maximum Strength

2% Salicylic Acid

works overnight to help eliminate existing blemishes
helps prevent new breakouts from forming
contains anti-inflammatory Bisabolol & soothing Aloe Vera to calm skin
fragrance- & oil-free formula

DERMATOLOGIST TESTED

exclusively at

CVS/pharmacy

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACID

salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-066
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
LAURETH-4 (UNII: 6HQ855798J)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
LEVOMENOL (UNII: 24WE03BX2T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-066-01	1 in 1 CARTON	05/01/2014
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	05/01/2014

Labeler - CVS Health (062312574)

Registrant - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)

Name	Address	ID/FEI	Business Operations
Establishment
AMCOL Health & Beauty Solutions, Inc. DBA		872684803	ANALYSIS(69842-066) , MANUFACTURE(69842-066) , LABEL(69842-066) , PACK(69842-066)

Revised: 3/2017

Document Id: aca57bce-04c3-47ee-ad55-0c0957e12453

Set id: 534cebb1-1c69-44b0-8407-e5863d7eaa31

Version: 1

Effective Time: 20170314