ACNEVIR- resorcinol, salicylic acid, sulphur gel

Acnevir by

Drug Labeling and Warnings

Acnevir by is a Homeopathic medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients.........................Purpose

Rescorcinol 2x................................Acne treatment

Salicylic Acid 3x..............................Acne treatment

Sulphur 1x......................................Acne treatment

PURPOSE

Purpose

Acne treatment

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.

INDICATIONS & USAGE

Uses

For the treatment of acne, redness and other eruptions of the skin.

WARNINGS

Warnings

For external use only.

Do not use on

• broken skin
• large areas of the skin

When using this product

• avoid contact with the eyes. Rinse right away with water if it gets in eyes.
• apply only to areas with acne
• skin irritations and dryness are more likely to occur if you use another topical acne medication at the time. If irritation occurs, use only one topical acne medication at a time.

Stop use and ask a doctor if

• skin irritation occurs or gets worse.

DOSAGE & ADMINISTRATION

Directions

• Read all package directions and warnings before use.
• Only only as directed.
• Clean skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer of Acnevir Gel one to three times a daily.
• Massage gently until absorbed into the skin.
• Because of 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.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• Intended for use by normally healthy individuals only.
• Persons under 18 years of age or those with sensitive of allergic skin should consult a doctor prior to use.
• Sensitivity Test for a New User. Apply product sparingly to one or two affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

INACTIVE INGREDIENT

Inactive ingredients

Acrylate, aloe barbadensis leaf juice, diazolidinyl urea, lactose, methylparaben, propylene glycol, propylparaben, tetrasodium EDTA, triethanolamine, water

QUESTIONS

Questions? 1-800-792-2582

OTHER SAFETY INFORMATION

Other information

You may report serious side effects to the phone number provided under Questions? below.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNEVIR 
resorcinol, salicylic acid, sulphur gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	1 [hp_X]  in 21.25 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 [hp_X]  in 21.25 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 [hp_X]  in 21.25 g

Inactive Ingredients
Ingredient Name	Strength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
EDETATE SODIUM (UNII: MP1J8420LU)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER 934 (UNII: Z135WT9208)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1080-04	21.5 g in 1 BOX; Type 0: Not a Combination Product	12/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/13/2018

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-1080)