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NDC 68062-9108-01 Pharmaskincare Acnecare Cream 0.025 mg/2.5mL Details

Pharmaskincare Acnecare Cream 0.025 mg/2.5mL

Pharmaskincare Acnecare Cream is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Spa de Soleil. The primary component is HYDROCORTISONE.

Product Information

NDC	68062-9108
Product ID	68062-9108_5b4eb36d-693c-d327-e053-2a91aa0a5eb3
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 Cream
Proprietary Name Suffix	n/a
Non-Proprietary Name	hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	0.025
Active Ingredient Units	mg/2.5mL
Substance Name	HYDROCORTISONE
Labeler Name	Spa de Soleil
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68062-9108-01 (68062910801)

Pricing Information	N/A
NDC Package Code	68062-9108-1
Billing NDC	68062910801
Package	60 mL in 1 TUBE (68062-9108-1)
Marketing Start Date	2017-10-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5b4e9be3-63e9-e4e2-e053-2991aa0abe97 Details

Active Ingredient

Hydrocortisone 1%

Purpose

External Analgesic

Warnings

For external use only.
Avoid contact with the eyes
If condition worsens or symptoms persist for more than seven days or clear up and occur again within a few days, stope use of this product and do not begin use of any hydrocortisone product until you have consulted a physician.
Do not use for the treatment of diaper rash. Consult a physician.
Keep out of reach of children.

Directions

Adults and children two years of age and older: Apply to affected area not more than three or four times daily. Children under two years of age: Do not use; consult a physician.

Uses:

For the temporary relief of itching associated with minor skin irritations and rashes. Other uses of this product should be only under the advice and supervision of a physician.

Inactive Ingredients:

Water, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Glycerin, Dimethicone, Propylene Glycol, Cetyl Alcohol, Sorbitol, Carthamus Tinctorius (Safflower) Seed Oil, **Squalane, Carbomer, Lactic Acid, Peg-4, Morus Alba Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Kojic Acid, Butylene Glycol, Arctostaphylos Uva-Ursi Leaf Extract, Sodium Hydroxide, Ruscus Aculeatus Root Extract, Ginkgo Biloba Leaf Extract, Diospyros Kaki Fruit Extract, Betula Alba Bark Extract, DMAE, Thioctic Acid, Ubiquinone, *CO Glycerin, Citric Acid, Malic Acid, Gluconic Acid, Ascorbic Acid (Vitamin C), Malus Domestica Fruit Cell Culture Extract, Glycolic Acid, Salicylic Acid, Tartaric Acid, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Xanthan Gum, Lecithin, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A), Benzyl Alcohol, Dehydroacetic Acid

Warning

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

Pharmaskincare Acnecare Soothing.jpg

INGREDIENTS AND APPEARANCE

PHARMASKINCARE ACNECARE CREAM

hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68062-9108
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.025 mg in 2.5 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68062-9108-1	60 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 not final	part348	10/10/2017

Labeler - Spa de Soleil (874682867)

Name	Address	ID/FEI	Business Operations
Establishment
Spa de Soleil		874682867	manufacture(68062-9108)

Revised: 10/2017

Document Id: 5b4eb36d-693c-d327-e053-2a91aa0a5eb3

Set id: 5b4e9be3-63e9-e4e2-e053-2991aa0abe97

Version: 1

Effective Time: 20171011