BLISTEX STRIDEX SPOT AND T-ZONE ACNE CLEARGEL- salicylic acid gel

Blistex Stridex Spot and T-Zone Acne ClearGel by

Drug Labeling and Warnings

Blistex Stridex Spot and T-Zone Acne ClearGel 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

• skin irritation and dryness is more 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.

Keep out of reach of children.

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

Directions

• 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
• keep away from eyes, lips and other mucous membranes

Inactive ingredients

aloe barbadensis leaf juice (decolorized), citric acid, ethylhexylglycerine, hamamelis virginiana (witch hazel) water, phenoxyethanol, purified water, PVM/MA decadiene crosspolymer, sodium borate, sodium hydroxide, tetrasodium EDTA

PRINCIPAL DISPLAY PANEL - 28.35 g Jar Carton

STRIDEX®
SALICYLIC ACID 2% W/W ACNE MEDICATION

SPOT & T-ZONE
ACNE CLEARGEL

new!

Focused Treatment For Problem Areas

Net Wt. 1 oz. (28.35 g)

INGREDIENTS AND APPEARANCE

BLISTEX STRIDEX SPOT AND T-ZONE ACNE CLEARGEL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2101
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
WATER (UNII: 059QF0KO0R)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MALEIC ANHYDRIDE (UNII: V5877ZJZ25)
1,9-DECADIENE (UNII: 2KWZ01G244)
METHYL VINYL ETHER (UNII: G2OHX46576)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2101-1	1 in 1 CARTON
1		28.35 g in 1 JAR; 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	01/04/2016

Labeler - Blistex Inc (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc		005126354	MANUFACTURE(10157-2101)