Search by Drug Name or NDC

NDC 10157-1010-01 Stridex 1 g/100mL Details

Stridex 1 g/100mL

Stridex is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Blistex Inc. The primary component is SALICYLIC ACID.

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 10157-1010-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	10157-1010
Product ID	10157-1010_60ddcf2e-40d7-4935-81ea-6ab9196a9eae
Associated GPIs	90750030004390
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stridex
Proprietary Name Suffix	Essential
Non-Proprietary Name	Salicylic Acid
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1
Active Ingredient Units	g/100mL
Substance Name	SALICYLIC ACID
Labeler Name	Blistex Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333D
Listing Certified Through	2022-12-31

Package

Package Images

NDC 10157-1010-01 (10157101001)

Pricing Information	N/A
NDC Package Code	10157-1010-1
Billing NDC	10157101001
Package	55 APPLICATOR in 1 JAR (10157-1010-1) / 2 mL in 1 APPLICATOR
Marketing Start Date	2012-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ebae4633-533d-41a1-9196-6f1674190c40 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 1.0% (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
use the pad to 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
do not leave pad on skin for an extended period of time
keep away from eyes, lips and other mucous membranes

Other information

DO NOT FLUSH - discard pad in trash and wash hands after use

Inactive ingredients

ammonium lauryl sulfate, ammonium xylenesulfonate, citric acid, DMDM hydantoin, fragrance, menthol, PEG-40 hydrogenated castor oil, PPG-26 Buteth-26, puriﬁed water, simethicone, sodium ascorbyl phosphate, sodium borate, tetrasodium EDTA, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 55 Pad Jar Carton

EASY ON SKIN –

TOUGH ON ACNE®

ALCOHOL

FREE

STRIDEX®

SALICYLIC ACID 1% W/W ACNE MEDICATION

ESSENTIAL WITH VITAMINS

55

Cleans • Treats • Prevents

SOFT

TOUCH

PADS

PRINCIPAL DISPLAY PANEL - 55 Pad Jar Carton

INGREDIENTS AND APPEARANCE

STRIDEX ESSENTIAL

salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10157-1010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ammonium lauryl sulfate (UNII: Q7AO2R1M0B)
ammonium xylenesulfonate (UNII: 4FZY6L6XCM)
citric acid monohydrate (UNII: 2968PHW8QP)
DMDM hydantoin (UNII: BYR0546TOW)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)
PPG-26-Buteth-26 (UNII: 2II1K6TZ4P)
water (UNII: 059QF0KO0R)
sodium ascorbyl phosphate (UNII: 836SJG51DR)
sodium borate (UNII: 91MBZ8H3QO)
edetate sodium (UNII: MP1J8420LU)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10157-1010-1	55 in 1 JAR	12/01/2012
1		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC:10157-1010-2	70 in 1 JAR	12/01/2012
2		2 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	12/01/2012

Labeler - Blistex Inc (005126354)

Name	Address	ID/FEI	Business Operations
Establishment
Blistex Inc		005126354	MANUFACTURE(10157-1010)

Revised: 12/2021

Document Id: 60ddcf2e-40d7-4935-81ea-6ab9196a9eae

Set id: ebae4633-533d-41a1-9196-6f1674190c40

Version: 4

Effective Time: 20211206