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NDC 69842-0464-52 CVS Health Advanced Acne Spot Treatment 20 mg/mL Details

CVS Health Advanced Acne Spot Treatment 20 mg/mL

CVS Health Advanced Acne Spot Treatment is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY. 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: 69842-0464-52
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	69842-0464
Product ID	69842-464_df24ce83-6144-44c0-e053-2995a90af52e
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	CVS Health Advanced Acne Spot Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	SALICYLIC ACID
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	mg/mL
Substance Name	SALICYLIC ACID
Labeler Name	CVS PHARMACY
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 69842-0464-52 (69842046452)

Pricing Information	N/A
NDC Package Code	69842-464-52
Billing NDC	69842046452
Package	1 TUBE in 1 CARTON (69842-464-52) / 22.1 mL in 1 TUBE (69842-464-51)
Marketing Start Date	2019-05-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4f1c74f-ee26-0e43-e053-2995a90a2972 Details

Active ingredient

Salicylic acid 2.0%

Purpose

Acne Medication

Uses

For the treatment of acne

Warnings

For external use only

FLAMMABLE: Keep away from spark, heat, or flame.

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, fluch thoroughly with water.

Keep out of reach of children.

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

Directions

Cleanse skin thoroughly before applying product.
Cover the entire afffected area with a thin layer one to three times daily.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

May stain some fabrics

Inactive ingredients

water, alcohol denat, hamamelis virginiana (witch hazel) extract, polyacrylamide, C13-14 isoparaffin, glycerin, cyclopentasiloxane, C12-15 alkyl lactate, laureth-7, phenoxyethanol, cetyl lactate, PPG-2 isoceteth-20 acetate, cocamidopropyl PG-dimonium chloride phosphate, polysorbate 20, phenethyl dimethicone, fragrance, dehydroxanthan gum, hexylene glycol, ammonium hydroxide, tetrasodium EDTA, butylene glycol, capryloyl glycine, sarcosine, cinnamomum zeylanicum bark extract, cedrus atlantica bark extract, portulaca oleracea extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS HEALTH ADVANCED ACNE SPOT TREATMENT

salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-464
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
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
LAURETH-7 (UNII: Z95S6G8201)
ALCOHOL (UNII: 3K9958V90M)
CINNAMON BARK OIL (UNII: XE54U569EC)
PURSLANE (UNII: M6S840WXG5)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIA (UNII: 5138Q19F1X)
CETYL LACTATE (UNII: A7EVH2RK4O)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SARCOSINE (UNII: Z711V88R5F)
EDETATE SODIUM (UNII: MP1J8420LU)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-464-52	1 in 1 CARTON	05/14/2019
1	NDC:69842-464-51	22.1 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	05/14/2019

Labeler - CVS PHARMACY (062312574)

Revised: 5/2022

Document Id: df24ce83-6144-44c0-e053-2995a90af52e

Set id: d4f1c74f-ee26-0e43-e053-2995a90a2972

Version: 2

Effective Time: 20220516