STRIDEX MAXIMUM- salicylic acid liquid

Stridex by

Drug Labeling and Warnings

Stridex by is a Otc medication manufactured, distributed, or labeled by Blistex Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 2.0% (w/w)

Purpose

Acne medication

Uses

• for the treatment of acne
• reduces the number of acne pimples and blackheads and allows skin to heal
• helps prevent new acne pimples from forming

Warnings

For external use only

Allergy alert

do not use this product if you have a known allergy to salicylic acid

When using this product

Using other topical acne medications at the same time or immediately following 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.

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

Directions

• cleanse the skin thoroughly before applying medication
• use the pad to wipe the entire affected area 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
• do not leave pad on skin for an extended period of time
• keep away from eyes, lips and other mucous membranes

Inactive ingredients

ammonium lauryl sulfate, ammonium xylenesulfonate, citric acid, DMDM hydantoin, fragrance, menthol, PPG-5-Ceteth-20, purified water, simethicone, sodium borate, tetrasodium EDTA

PRINCIPAL DISPLAY PANEL - 110 Applicator Jar Carton

NDC: 10157-1006-7

BONUS
20%
MORE

SINGLE-STEP
ACNE CONTROL ®

ALCOHOL
FREE

STRIDEX ®
SALICYLIC ACID 2% W/W ACNE MEDICATION

MAXIMUM
110

SOFT
TOUCH
PADS

INGREDIENTS AND APPEARANCE

STRIDEX  MAXIMUM
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-1006
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 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
MENTHOL (UNII: L7T10EIP3A)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-1006-1	1 in 1 CARTON	12/01/2012
1		55 in 1 JAR
1		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 10157-1006-3	1 in 1 CARTON	12/01/2012
2		70 in 1 JAR
2		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 10157-1006-2	1 in 1 CARTON	12/01/2012
3		90 in 1 JAR
3		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC: 10157-1006-4	1 in 1 CARTON	12/01/2012
4		110 in 1 JAR
4		2 mL in 1 APPLICATOR; 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	12/01/2012

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	manufacture(10157-1006)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	manufacture(10157-1006)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		829295349	manufacture(10157-1006)