CLEAR-N-SMOOTH- acne-pimple medication lotion 
Hawknad Manufacturing Industries, 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.

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Listing for Clear-N-Smooth Acne-Pimple Medication

Indications for Use

For the Treatment of Acne Pimples

Purpose

Acne Treatment

Dosage

Moisten a cotton ball and apply a thin layer over the entire affected area.

Keep Out of Reach of Children

For External Use Only. Keep Out of reach of Children.

Warnings

For External Use Only

Flammable. Keep away from open flame or fire.

When Using this Product

Instructions for Use

Cleanse the skin thoroughly before applying medication. Moisten a cotton ball with the lotion and cover the entire affected area with a thin layer one to three times daily. 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.

Inactive Ingredients

alcohol, water, propylene glycol, dimethicone copolyol, disodium EDTA, benzophenone-4, menthol, sodium bicarbonate, blue #1, fragrance.

Active Ingredient

Salicylic Acid - 1.0%

Principal Display Panel

Label

CLEAR-N-SMOOTH 
acne-pimple medication lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76445-0091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 0.45 g  in 1 g
WATER (UNII: 059QF0KO0R) 0.49 g  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.02 g  in 1 g
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.01 g  in 1 g
SULISOBENZONE (UNII: 1W6L629B4K) 0.001 g  in 1 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.00005 g  in 1 g
DIMETHICONOL (40 CST) (UNII: 343C7U75XW) 0.005 g  in 1 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.001 g  in 1 g
LEVOMENTHOL (UNII: BZ1R15MTK7) 0.0005 g  in 1 g
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76445-0091-6176 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/02/1992
Labeler - Hawknad Manufacturing Industries, Inc. (618892426)
Registrant - Hawknad Manufacturing Industries, Inc. (618892426)
Establishment
NameAddressID/FEIBusiness Operations
EMS Acquisition Group048602791manufacture(76445-0091)

Revised: 1/2023
Document Id: f1f4876f-dda3-dd9a-e053-2a95a90a4636
Set id: 13c770df-63db-32d2-e054-00144ff88e88
Version: 8
Effective Time: 20230110
 
Hawknad Manufacturing Industries, Inc.