DR SONG ACNE- benzoyl peroxide gel 
Secret By Nature LLC

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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Dr Song Acne

ACTIVE INGREDIENT

 Active Purpose
 BENZOYL PEROXIDEAcne Treatment 

INACTIVE INGREDIENT


CARBOMER,EDETATE DISODIUM, GLYCERINE, PROPYLENE GLYCOL, SACCHARIDE ISOMERATE, SODIUM HYDROXIDE, WATER

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

For the treatment of acne

WARNINGS

For external use only. 

Do to use if you:

When using this product

DIRECTIONS

PURPOSE

For the treatment of acne.

Stop use and ask a doctor if:


Sensitivity develops or irritation becomes severe, stop us and ask a doctor.

Distributed By:

Dr Song,

2250 E Enterprise Pkwy

TWINSBURG, OH, 44089

Other Information:

Store: At Room Temperature 15° - 25°C (59°- 77°F). Protect from heat. Keep container tightly closed.

Dr Song Acne 2.5%

Label Image

Dr Song Acne 10%

Label Image
DR SONG ACNE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71174-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71174-100-01227 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2015
DR SONG ACNE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71174-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71174-200-01227 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/01/2015
Labeler - Secret By Nature LLC (079571146)
Establishment
NameAddressID/FEIBusiness Operations
Pharmco Laboratories Inc096270814MANUFACTURE(71174-100, 71174-200)

Revised: 1/2017
Document Id: 9950683a-271a-4be3-b6c6-3466cebe79af
Set id: 4de9c366-c39c-4162-8359-c5dfc67ddaa5
Version: 2
Effective Time: 20170112
 
Secret By Nature LLC