ACNEVIR- sulphur, resorcinol, salicylic acid gel 
Alva-Amco Pharmacal Companies, Inc.

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


Resorcinol 2x

Salicylic Acid 3x

Sulphur 1x

Purpose

 Acne treatment

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 irritation and dryness are more likely to occur if you use another topical acne medication at the same 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.

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

Directions

  • Read all package directions and warnings before use.
  • Use 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 time daily.
  • Massage gently until absorbed into the skin.
  • Because 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 or allergic skin should consult a doctor prior to use.
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Other information

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

Inactive ingredients

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

Questions? 1-800-792-2582

Acnevir ®

Adult Acne & Redness Relief

With Aloe

Triple Action Adult Acne Relief

  1. Clears Acne Pimples
  2. Reduces Redness
  3. Prevents Future Breakouts

Specially formulated to treat Adult Acne, ACNEVIR contains THREE active ingredients versus just one in most other brands. ACNEVIR's unique formula is also designed to be less harsh on sensitive adult skin, with aloe and no drying benzoyl peroxide or alcohol.

ABOUT ACNEVIR ® Gel:

ACNEVIR Adult Acne & Redness Relief Gel combines science and convenience to help restore beautiful skin. ACNEVIR is formulated for adults and contains three medically recognized homeopathic ingredients in a non-oily formula that clears acne pimples and blackheads, reduces redness and helps restore skin's natural appearance. ACNEVIR is formulated to be gentle on skin and to help smooth, calm and normalize affected areas with no drying alcohol or benzoyl peroxide. With daily use, ACNEVIR Adult Acne & Redness Relief Gel can help restore a healthy appearance and prevent recurrence of breakouts.

WHY ADULT ACNE IS DIFFERENT:

Facial breakouts can often continue to plague men and women well into their 30s, 40s, and even 50s.

A study 1 examining the prevalence of acne in adults over age 20 found that acne affects more than 50 percent of women between the ages of 20-29 and more than 25 percent of women between the ages of 40-49. The study also found that a disproportionate number of adult women were affected by acne compared to similar-aged men.

Dermatologists call acne that does not clear by one's mid-20s "persistent acne". Persistent acne can cause tender, deep-seated, inflamed pimples and nodules around the mouth, chin, and jawline that can be difficult to treat.

Acne can also suddenly recur in adults after years of clear skin. Late-onset acne is also more frequently seen in women and can often appear around menopause. Hormones are primarily to blame for this acne that can form on the chin, jawline, around the mouth, and even on the chest and back.

WHAT CAUSES ADULT ACNE?

Adult acne is caused when sebum, an oily substance produced by the skin's sebaceous glands, clogs pores. Clogged pores can attract bacteria and become inflamed. For some adults, breakouts are a result of an imbalance in hormones. For women, this can happen during pregnancy, peri-menopause, and menopause. Some medications, such as corticosteroids, and cosmetics can also contribute to the development of acne.

There are many contributing factors that can cause adult acne. Here is a list of the most common offenders:

  • Fluctuating hormones
  • Discontinuing birth control pills
  • Taking certain medications
  • Family history of acne
  • Stress
  • Products used on hair and skin

HOW IS TREATING ADULT ACNE DIFFERENT THAN TREATING TEEN ACNE?

Adult acne can be particularly frustrating. Treatments that worked well during adolescence can often be ineffective or overly drying. Many common over-the-counter topical medications designed for oily teenaged skin can irritate adult skin, making acne worse.

Adult women are more likely to have thinner, drier skin as they get older, and using ingredients such as benzoyl peroxide that are found in many teen acne medications may actually cause more skin irritation.

WHILE USING ACNEVIR, HERE ARE SOME IMPORTANT ADDITIONAL WAYS TO KEEP YOUR ACNE SYMPTOMS UNDER CONTROL:

  • Use non-comedogenic or sensitive skin products to reduce the formation of new acne blemishes and to minimize skin irritation.
  • Wash the affected area with a mild cleanser twice a day.
  • Avoid cleansers or other skin care products with scrubbing particles or a gritty texture, as they can irritate the skin.
  • Use a non-comedogenic moisturizer daily.
  • Avoid picking, squeezing, popping or touching acne blemishes to minimize trauma to the skin and to help reduce the risk of scarring and secondary bacterial infections.

Active ingredients

Resorcinol 2x

Salicylic Acid 3x

Sulphur 1x

Purpose: Acne treatment

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 irritation and dryness are more likely to occur if you use another topical acne medication at the same 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.

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

Directions: • Read all package directions and warnings before use. • Use 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 daily • Massage gently until absorbed into the skin. • Because 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 or allergic skin should consult a doctor prior to use • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

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

Inactive ingredients Acrylates, aloe barbadensis leaf juice, diazolidinyl urea, lactose, methylparaben, propylene glycol, propylparaben, tetrasodium EDTA, triethanolamlne, water.

Questions? 1-800-792-2582 www.ACNEVIR.com

GLUTEN FREE

1Collier CN, Harper JC, Cafardi JA, Cantrell WC, Wang W, Foster KW, Elewski BE. "The prevalence of acne in adults 20 years and older". Journal of The American Academy of Dermatology 2008 Jan;58(1):56-59. Epub 2007 Oct 22.

AcneVir Gel PDP

ACNEVIR 
sulphur, resorcinol, salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 [hp_X]  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 [hp_X]  in 1 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 934 (UNII: Z135WT9208)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
LACTOSE (UNII: J2B2A4N98G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-608-211 in 1 CARTON12/01/200904/30/2018
1NDC:52389-608-0121.25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/200904/30/2018
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 12/2018
 
Alva-Amco Pharmacal Companies, Inc.