R-044 Blemish Fix: Package Insert and Label Information

R-044 BLEMISH FIX- salicylic acid liquid
CBI Laboratories, Inc

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.

Drug Facts

Active Ingredients

Salicylic Acid 2.0%

Purpose

Acne treatment

Uses

  • penetrates pores to clear most acne blemishes. Helps keep skin clear of pimples.

Warnings

For external use only.

Using other acne medication at the same time or immediately following the 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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Cleanse the skin thoroughly before applying medication.
  • Shake well before use.
  • Apply a thin layer directly to affected areas one to three times daily.

Inactive Ingredients

Camphor, Hamamelis Virginiana (Witch Hazel) Extract, SD Alcohol 40, Water (Aqua)

PRINCIPAL DISPLAY PANEL — 6.8 mL Carton

blemish fix

OIL — FREE SYSTEM

.23 fl Oz / 6.8 mL

Principal Display Panel -- 6.8 mL Carton
(click image for full-size original)
R-044 BLEMISH FIX
salicylic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24623-044
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24623-044-23 6.8 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 03/28/2006
Labeler — CBI Laboratories, Inc (623704368)
Establishment
Name Address ID/FEI Operations
CBI Laboratories, Inc. 623704368 MANUFACTURE

Revised: 01/2011 CBI Laboratories, Inc

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