THERASPEC ACNE CLEANSER- benzoyl peroxide soap

TheraSpec by

Drug Labeling and Warnings

TheraSpec by is a Otc medication manufactured, distributed, or labeled by Salient Labs, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TheraSpec therapeutic specific cleansers Acne Cleanser Micronized BPO Drug Facts Panel

Active Ingredient

Benzoyl Peroxide 5%

PURPOSE

Acne medication

Use

for the treatment of acne

Warnings

For external use only

DO NOT USE

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide

WHEN USING

When using this product

• keep away from eyes, lips and mouth
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with hair, dyed fabric, including carpet and clothing which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. lf irritation becomes severe, discontinue use: if irritation still continues, consult a doctor.
• using other topical acne medications 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

DOSAGE & ADMINISTRATION

Directions Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for use twice daily.

INACTIVE INGREDIENT

Inactive Ingredients Acrylates Copolymer, Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Ceteareth-20, Dehydroacetic Acid, Hydrolyzed Jojoba Esters, lsopentyldiol, Jojoba Esters, Sodium Cocyl lsethionate.

PRINCIPAL DISPLAY PANEL

TheraSpec

Acne Cleanser

Principal Display Panel

221 ml

NDC: 52205-003-00

INGREDIENTS AND APPEARANCE

THERASPEC  ACNE CLEANSER
benzoyl peroxide soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52205-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52205-003-00	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/18/2019

Labeler - Salient Labs, LLC (130977940)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(52205-003)