Betamethasone Valerate (Page 2 of 2)

ADVERSE REACTIONS:

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

OVERDOSAGE:

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION:

Apply a thin film of Betamethasone Valerate Cream or Ointment to the affected skin areas one to three times a day. Dosage once or twice a day is often effective.

Apply a few drops of Betamethasone Valerate Lotion to the affected area and massage lightly until it disappears. Apply twice daily, in the morning and at night. Dosage may be increased in stubborn cases. Following improvement, apply once daily. For the most effective and economical use, apply nozzle very close to affected area and gently squeeze bottle.

HOW SUPPLIED:

Betamethasone Valerate Cream USP, 0.1% supplied as follows

NDC: 70518-0721-00

PACKAGING: 15 g in 1 TUBE

Store at room temperature 15° — 30°C (59° — 86°F) [see USP Controlled Room Temperature].

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Betamethasone Valerate

GENERIC: betamethasone valerate

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0721-0

PACKAGING: 15 g in 1 TUBE

ACTIVE INGREDIENT(S):

• BETAMETHASONE VALERATE 1mg in 1g

INACTIVE INGREDIENT(S):

• WATER
• MINERAL OIL
• PETROLATUM
• CETETH-20
• CETOSTEARYL ALCOHOL
• SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
• PHOSPHORIC ACID
• SODIUM HYDROXIDE
• CHLOROCRESOL

BETAMETHASONE VALERATE betamethasone valerate cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0721(NDC:0168-0040) Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETAMETHASONE VALERATE (BETAMETHASONE) BETAMETHASONE 1 mg in 1 g

Inactive Ingredients Ingredient Name Strength WATER MINERAL OIL PETROLATUM CETETH-20 CETOSTEARYL ALCOHOL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHORIC ACID SODIUM HYDROXIDE CHLOROCRESOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70518-0721-0 15 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018861 08/31/2017

Labeler — REMEDYREPACK INC. (829572556)

Revised: 01/2021 REMEDYREPACK INC.