ACNEVIR- resorcinol, salicylic acid, sulphur gel 
Denison Pharmaceuticals, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Acnevir Gel

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

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

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

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

Purpose

Acne treatment

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Uses

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

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.

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 ingredients

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

Questions? 1-800-792-2582

Other information

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

label

ACNEVIR 
resorcinol, salicylic acid, sulphur gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 [hp_X]  in 21.25 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 [hp_X]  in 21.25 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 [hp_X]  in 21.25 g
Inactive Ingredients
Ingredient NameStrength
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)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1080-0421.5 g in 1 BOX; Type 0: Not a Combination Product12/13/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/13/201809/21/2021
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-1080)

Revised: 9/2021
 
Denison Pharmaceuticals, LLC