DrugInserts.com: Trustworthy FDA Drug Information

Over the Counter Medications

Package Insert and Label Information: Skin Perfecting Acne and Blemish Wash

By Biocosmetics Research Labs | Last revised: 19 June 2006

SKIN PERFECTING ACNE AND BLEMISH WASH — salicylic acid rinse
Biocosmetics Research Labs

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient:

Salicylic Acid 0.50%


Purpose:

Acne Treatment Wash


Use:

For the treatment of acne. Clears up most of the acne blemishes, acne pimples, blackheads and whiteheads.


Warnings:

For external use only.

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.


Directions:

Cleanse the skin twice daily, rinse with warm water.


Sensitivity test for 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 Ingredients:

Water, Sodium Laureth Sulfate, Disodium Laureth Sulfosuccinate, Acrylates/C10-30 Alkyl Acrylates Copolymer, Propylene Gylcol, Polysorbate 20, Microcellulose, Lactose, Tocopheryl Acetate, Retinyl Palmitate, Urtica Dioica (Nettle) Extract, Salix Alba (Willow) Bark Extract, Hamamelis Virginiana (Witch Hazel) Extract, Microcrystalline Cellulose, Triclosan, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Benzophenone-4, Sodium hydroxide, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Ultramarines (CI 77007).

Image of acnewash carton

SKIN PERFECTING ACNE AND BLEMISH WASH
salicylic acid rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59735-314
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 0.50 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59735-314-06 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 180 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59735-314-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 06/19/2006
Labeler — Biocosmetics Research Labs (078870292)

Revised: 06/2006 Biocosmetics Research Labs