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NDC 73469-0753-01 Scholls Wellness Company LLC 0.4 g/g Details

Scholls Wellness Company LLC 0.4 g/g

Scholls Wellness Company LLC is a TOPICAL DISC in the HUMAN OTC DRUG category. It is labeled and distributed by Scholls Wellness Company LLC. 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: 73469-0753-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	73469-0753
Product ID	73469-0753_d65651f0-6225-0697-e053-2995a90abc06
Associated GPIs
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	Scholls Wellness Company LLC
Proprietary Name Suffix	One Step Corn Removers
Non-Proprietary Name	Salicylic Acid
Product Type	HUMAN OTC DRUG
Dosage Form	DISC
Route	TOPICAL
Active Ingredient Strength	0.4
Active Ingredient Units	g/g
Substance Name	SALICYLIC ACID
Labeler Name	Scholls Wellness Company LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358F
Listing Certified Through	2023-12-31

Package

Package Images

NDC 73469-0753-01 (73469075301)

Pricing Information	N/A
NDC Package Code	73469-0753-1
Billing NDC	73469075301
Package	6 POUCH in 1 CARTON (73469-0753-1) / 1 g in 1 POUCH
Marketing Start Date	2021-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7f98d59c-fc89-545b-e053-2a91aa0a49e6 Details

Drug Facts

Active Ingredient

Active Ingredient Purpose

Salicylic Acid 40%.......................Corn remover

Purpose

Corn remover

Uses

for the removal of corns
relieves pain by removing corns

Warnings

For external use only

Do not use

if you are a diabetic
if you have poor blood circulation
on irritated skin or any area that is infected or reddened

Stop use and ask a doctor

Stop use and ask a doctor if discomfort lasts

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.

Directions

wash affected area and dry thoroughly
apply medicated bandage
after 48 hours, remove medicated bandage
repeat procedure every 48 hours as needed for up to 14 days (until corn is removed)
may soak corn in warm water for 5 minutes to assist removal

Other information

store between 20ºC to 25ºC (68º to 77ºF).
Protect from excessive heat (temperatures above 40ºC (104ºF))

Inactive ingredients

Inactive ingredients antioxidant

(CAS 991-84-4), iron oxides, mineral oil,

petroleum hydrocarbon resin, silicon dioxide,

synthetic polyisoprene rubber, talc

Questions

Questions? 1-866-360-3226

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SCHOLLS WELLNESS COMPANY LLC ONE STEP CORN REMOVERS

salicylic acid disc

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73469-0753
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.4 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MINERAL OIL (UNII: T5L8T28FGP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73469-0753-1	6 in 1 CARTON	01/01/2021
1		1 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358F	01/01/2021

Labeler - Scholls Wellness Company LLC (117174744)

Registrant - Scapa Tapes North America LLC (079995435)

Revised: 1/2022

Document Id: d65651f0-6225-0697-e053-2995a90abc06

Set id: 7f98d59c-fc89-545b-e053-2a91aa0a49e6

Version: 2

Effective Time: 20220124