DR SONG ACNE- benzoyl peroxide gel

Dr Song Acne by

Drug Labeling and Warnings

Dr Song Acne by is a Otc medication manufactured, distributed, or labeled by Secret By Nature LLC, Pharmco Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active: Purpose
• BENZOYL PEROXIDE: Acne 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. 

• Avoid unnecessary sun exposure and use a sunscreen
• Avoid contact with the eyes, lips, and mouth
• Avoid contact with hair and dyed fabrics, which may be bleached by this product
• Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
• If going outside, apply sunscreen after using this product.
• Keep away from excessive heat or heat sources

Do to use if you:

• Have very sensitive skin 
• Are sensitive to benzoyl peroxide.

When using this product

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

DIRECTIONS

• Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer one to three times daily Use about a quarter sized amount.
• 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.
• Other sun protection measures include limiting sun exposure and wearing protective clothing.

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%

Dr Song Acne 10%

INGREDIENTS AND APPEARANCE

DR SONG ACNE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71174-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71174-100-01	227 g in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2015

DR SONG ACNE 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71174-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71174-200-01	227 g in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2015

Labeler - Secret By Nature LLC (079571146)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories Inc		096270814	MANUFACTURE(71174-100, 71174-200)