Theraspec Acne Cleanser

Theraspec Acne Cleanser
SPL v5
SPL
SPL Set ID 83e6d5d5-a626-0bdc-e053-2991aa0a6351
Route
TOPICAL
Published
Effective Date 2019-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (5 g)
Inactive Ingredients
Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Hydrolyzed Jojoba Esters (acid Form) Allantoin Water Sodium Cocoyl Isethionate Dehydroacetic Acid Isopentyldiol Jojoba Oil, Randomized Benzyl Alcohol Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-04-18

Description

Benzoyl Peroxide 5%


Medication Information

Dosage and 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.

Description

Benzoyl Peroxide 5%

Use

for the treatment of acne

Section 50565-1

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.

Section 50567-7

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.
Section 50570-1

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

Section 51727-6

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

Section 51945-4

TheraSpec

Acne Cleanser

Principal Display Panel

221 ml

NDC: 52205-003-00

Section 55105-1

Acne medication

Warnings

For external use only

Active Ingredient

Benzoyl Peroxide 5%


Structured Label Content

Use

for the treatment of acne

Dosage and Administration (34068-7)

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.

Section 50565-1 (50565-1)

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.

Section 50567-7 (50567-7)

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.
Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

TheraSpec

Acne Cleanser

Principal Display Panel

221 ml

NDC: 52205-003-00

Section 55105-1 (55105-1)

Acne medication

Warnings

For external use only

Active Ingredient

Benzoyl Peroxide 5%


Advanced Ingredient Data


Raw Label Data

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