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NDC 75990-0914-03 Satin Foam High Foaming Antiseptic Hand Wash 3 mg/mL Details

Satin Foam High Foaming Antiseptic Hand Wash 3 mg/mL

Satin Foam High Foaming Antiseptic Hand Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Certus Medical, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	75990-0914
Product ID	75990-914_ea49da65-ae5f-bfde-e053-2a95a90adef2
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	Satin Foam High Foaming Antiseptic Hand Wash
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHLOROXYLENOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	mg/mL
Substance Name	CHLOROXYLENOL
Labeler Name	Certus Medical, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 75990-0914-03 (75990091403)

Pricing Information	N/A
NDC Package Code	75990-914-03
Billing NDC	75990091403
Package	750 mL in 1 BAG (75990-914-03)
Marketing Start Date	2022-10-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ea49da65-ae5e-bfde-e053-2a95a90adef2 Details

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.3%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

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

Drug Facts Box OTC-Dosage & Administration Section

wet hands and forearms
apply 5 milliliters (teaspoonful) or palmful to hands and forearms
scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, DMDM hydantoin, methylchloroisothiazolinone, methylisothiazolinone, fragrance, aloe barbadensis, acid red 1

Satin Foam High Foaming Antiseptic Hand Wash Drug 6914

INGREDIENTS AND APPEARANCE

SATIN FOAM HIGH FOAMING ANTISEPTIC HAND WASH

chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75990-914
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ACID RED 1 (UNII: 3365R6427R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75990-914-03	750 mL in 1 BAG; Type 0: Not a Combination Product	10/05/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/05/2022

Labeler - Certus Medical, Inc. (118806847)

Registrant - ABC Compounding Co., Inc. (003284353)

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(75990-914)

Revised: 10/2022

Document Id: ea49da65-ae5f-bfde-e053-2a95a90adef2

Set id: ea49da65-ae5e-bfde-e053-2a95a90adef2

Version: 1

Effective Time: 20221005