Salicylic Acid by D3 Development, Inc. SALICYLIC ACID soap

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by D3 Development, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Salicylic acid 2%

PURPOSE

Purpose

Acne treatment

INDICATIONS & USAGE

Uses

• For the treatment of acne
• Reduces the number of acne pimples and allows skin to heal
• Penetrates pores to clear most acne blemishes
• Dries up acne pimples
• Helps keep skin clear of new acne blemishes, acne pimples, whiteheads, and blackheads

WARNINGS

Warnings

For external use only

WHEN USING

When using this product, skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time 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.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eyes.
• Rinse thoroughly and pat dry with a clean towel
• Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

STORAGE AND HANDLING

Other information

• Store at room temperature
• Lot number and expiration date are printed on back panel.

INACTIVE INGREDIENT

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, table salt, olive oil, Avena Sativa (oat) kernel flour, pentasodium pentetate, tocopheryl acetate (vitamin E)

QUESTIONS

Questions?

1-800-827-3730

www.dermaharmony.com

SPL UNCLASSIFIED SECTION

Distributed by:

D3 Development, Inc., Portland, ME 04101

Made in the USA

PRINCIPAL DISPLAY PANEL

dermaharmony

Salicylic Acid SOAP

For Acne, Whiteheads, & Blackheads

NET WT 4.0 OZ (113 G)

INGREDIENTS AND APPEARANCE

SALICYLIC ACID 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM COCOATE (UNII: R1TQH25F4I)
GLYCERIN (UNII: PDC6A3C0OX)
OATMEAL (UNII: 8PI54V663Y)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PALMATE (UNII: S0A6004K3Z)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-003-04	113 g in 1 CELLO PACK; Type 0: Not a Combination Product	05/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/04/2018

Labeler - D3 Development, Inc. (043195877)