Search by Drug Name or NDC

NDC 68062-9110-01 Pharmaskincare Acnecare Exfoliator 0.013 mg/2.5mL Details

Pharmaskincare Acnecare Exfoliator 0.013 mg/2.5mL

Pharmaskincare Acnecare Exfoliator is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Spa de Soleil. The primary component is SALICYLIC ACID.

Product Information

NDC	68062-9110
Product ID	68062-9110_5b501566-02a5-1801-e053-2a91aa0ae5da
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	Pharmaskincare Acnecare Exfoliator
Proprietary Name Suffix	n/a
Non-Proprietary Name	salicylic acid
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	0.013
Active Ingredient Units	mg/2.5mL
Substance Name	SALICYLIC ACID
Labeler Name	Spa de Soleil
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 68062-9110-01 (68062911001)

Pricing Information	N/A
NDC Package Code	68062-9110-1
Billing NDC	68062911001
Package	120 mL in 1 TUBE (68062-9110-1)
Marketing Start Date	2017-10-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5b501566-02a4-1801-e053-2a91aa0ae5da Details

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

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.

Directions

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer and rinse thoroughly 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.

Massage Acnecare Exfoliator onto cleansed, damp skin with fingertips using a circular motion. Rinse well with lukewarm water and pat dry. Avoid use on flare-ups and breakouts.

Uses:

For the treatment of acne.

Inactive Ingredients:

Water, Phytelephas Aequatorialis Seed Powder, Glycerin, Glyceryl Stearate SE, Cocamidopropyl Betaine, Carthamus Tinctorius (Safflower) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Hydroxyethylcellulose, *CO Glycerin, *CO Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Papain, *CO Aesculus Hippocastanum (Horse Chestnut) Seed Extract, *CO Prunus Armeniaca (Apricot) Fruit Extract, *CO Rosa Centifolia Flower Extract, *CO Rosmarinus Officinalis (Rosemary) Leaf Extract, **Squalane, DMAE, Thioctic Acid, Ubiquinone, Carica Papaya (Papaya) Fruit Extract, Sea Salt (Dead Sea Salt), Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Citric Acid, Lactic Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Lecithin, Glycolic Acid, Tartaric Acid, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Fragrance, Dehydroacetic Acid

Warning

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Pharmaskincare AcnecareExfoliator.jpg

INGREDIENTS AND APPEARANCE

PHARMASKINCARE ACNECARE EXFOLIATOR

salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68062-9110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.013 mg in 2.5 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SAFFLOWER OIL (UNII: 65UEH262IS)
PHYTELEPHAS AEQUATORIALIS SEED (UNII: 2DJN5A6ONH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68062-9110-1	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	10/10/2017

Labeler - Spa de Soleil (874682867)

Name	Address	ID/FEI	Business Operations
Establishment
Spa de Soleil		874682867	manufacture(68062-9110)

Revised: 10/2017

Document Id: 5b501566-02a5-1801-e053-2a91aa0ae5da

Set id: 5b501566-02a4-1801-e053-2a91aa0ae5da

Version: 1

Effective Time: 20171011