DERMOPLAST POST PARTUM- benzocaine aerosol, spray

Dermoplast Post Partum by

Drug Labeling and Warnings

Dermoplast Post Partum by is a Otc medication manufactured, distributed, or labeled by Advantice Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ingredient: Benzocaine 20% Purpose: Local Anesthetic

DOSAGE & ADMINISTRATION

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting and blotting with an appropriate cleansing pad.
Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
Hold can 6 to 12 inches away from affected area. Direct the spray nozzle towards the skin and press the button to activate spray.
Apply to the affected area up to 6 times daily.
Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT

acetylated lanolin alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben USP, PEG-400 monolaurate, menthol, polysorbate 85

WARNINGS

For external use only

Flammable: do not use near heat, flame, or fire or while smoking
When using this product:
Do not exceed the recommended daily dosage unless directed by a doctor.
Do not get into eyes.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal.
Do not puncture or incinerate. Contents under pressure.
Do not store at temperatures above 120°F.

Stop use and ask a doctor if:
Condition worsens or does not improve within 7 days.
Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
In case of bleeding, consult a doctor promptly
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

helps relieve the itching and discomfort in the perianal area. for temporary relief of pain, soreness and burning.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Local Anesthetic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMOPLAST POST PARTUM 
benzocaine aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-640
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 85 (UNII: A7F3N56197)
CETYL ACETATE (UNII: 4Q43814HXS)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTANE (UNII: 6LV4FOR43R)
MENTHOL (UNII: L7T10EIP3A)
PEG-8 LAURATE (UNII: 762O8IWA10)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-640-01	78 g in 1 CAN; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/01/2025

Labeler - Advantice Health, LLC (192527062)