SKINMEDICA ACNE TREATMENT- benzoyl peroxide lotion

SkinMedica Acne Treatment by

Drug Labeling and Warnings

SkinMedica Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Allergan, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

Use

• For the treatment of acne
• Dries up acne pimples. Helps prevent new acne pimples

Warnings

For external use only

Do not use if you

• Have very sensitive skin
• Are sensitive to benzoyl peroxide

When using this product

• Skin irritation and dryness is most 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
• 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

Stop use and ask a doctor if

• Irritation becomes severe

Keep out of reach of children

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

Directions AM/PM

• Clean the skin thoroughly before applying this product
• 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
• If going outside, apply sunscreen after using this product. If irritation develops, stop use of both products and ask a doctor
• Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other information

Store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

Water, Methyl Methacrylate/Glycol Dimethylacrylate Crosspolymer, C12-15 Alkyl Benzoate, Polyacrylate-13, Hydroxyphenyl Propamidonezoic Acid, Salix Nigra (Willow) Bark Extract, Hamamelis Virgiana (Witch Hazel) Bark/Leaf/Twig Extract, Salvia Officinalis (Sage) Leaf Extract, Allantoin, Bisabolol, Butylene Glycol, Pentylene Glycol, Xanthan Gum, Polyisobutene, Polysorbate 20, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate

PRINCIPAL DISPLAY PANEL

SkinMedica®

Acne Treatment
Lotion

This elegantly formulated benzoyl peroxide-based therapeutic lotion fights the causes of acne, restoring balance to the skin for a more healthy and radiant complexion.

ACNE

Net Wt. 56.7 g / 2 Oz.

INGREDIENTS AND APPEARANCE

SKINMEDICA ACNE TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0023-4965
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
allantoin (UNII: 344S277G0Z)
levomenol (UNII: 24WE03BX2T)
butylene glycol (UNII: 3XUS85K0RA)
alkyl (C12-15) benzoate (UNII: A9EJ3J61HQ)
edetate disodium (UNII: 7FLD91C86K)
ethylhexylglycerin (UNII: 147D247K3P)
hamamelis virginiana root bark/stem bark (UNII: T7S323PKJS)
hydroxyphenyl propamidobenzoic acid (UNII: 25KRT26H77)
methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)
pentylene glycol (UNII: 50C1307PZG)
phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
Polyisobutylene (35000 MW) (UNII: 98553S1MHQ)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Salix Nigra Bark (UNII: QU52J3A5B3)
Sage (UNII: 065C5D077J)
water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0023-4965-02	1 in 1 CARTON	01/01/2013
1		56.7 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2013

Labeler - Allergan, Inc. (144796497)