ANTI-ITCH VULVA CREAM 1 HYDROCORTISONE ACETATE- hydrocortisone acetate cream

Anti-Itch Vulva Cream 1 Hydrocortisone Acetate by

Drug Labeling and Warnings

Anti-Itch Vulva Cream 1 Hydrocortisone Acetate by is a Otc medication manufactured, distributed, or labeled by The Honey Pot Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Hydrocortisone Acetate 1%

Purpose

Anti-Itch

Uses:

For the temporary relief of external feminine itching.

Warnings:

For external use only

When using this product:

avoid contact with eyes.

Stop use and ask doctor if:

• Condition worsens
• If symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Do not use if:

you have vaginal discharge. Consult a physician.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

Apply to affected area not more than 3 to 4 times daily. Adults and children 12 years of age and older:Children under 12 years of age: Consult a doctor

Inactive Ingredients:

Adansonia Digitata Seed Oil, Allantoin, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C10-18 Triglycerides, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylhydroxamic Acid, Caprylyl Glyceryl Ether, Ceramide NG, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Limonene, Linalool, Melia Azadirachta Seed Oil, Mentha Piperita (Peppermint) Oil, Myristyl Alcohol, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Propolis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Phytate, Sodium Stearoyl Lactylate, Steareth-30, Stearic Acid, Steary Alcohol, Sucrose Palmitate, Theobroma Cacao (Cocoa) Seed Butter, Water, Xanthan Gum

Questions:

For questions and general information visit us at www.thehoneypot.co/contact

Package Labeling:

INGREDIENTS AND APPEARANCE

ANTI-ITCH VULVA CREAM 1 HYDROCORTISONE ACETATE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82637-9455
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
PEPPERMINT OIL (UNII: AV092KU4JH)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPANEDIOL (UNII: 5965N8W85T)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHYTATE SODIUM (UNII: 88496G1ERL)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
STEARETH-30 (UNII: 5776GCL1DG)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
COCOA BUTTER (UNII: 512OYT1CRR)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SHEA BUTTER (UNII: K49155WL9Y)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)
CERAMIDE NG (UNII: C04977SRJ5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82637-9455-1	1 in 1 CARTON	03/01/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/01/2022

Labeler - The Honey Pot Company LLC (045600502)