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NDC 63830-0876-03 Suds High Foaming Antiseptic Hand and Body Wash 3 mg/mL Details

Suds High Foaming Antiseptic Hand and Body Wash 3 mg/mL

Suds High Foaming Antiseptic Hand and Body Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Pro chem, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	63830-0876
Product ID	63830-876_f0faa719-7892-40cc-963f-27a971407c55
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	Suds High Foaming Antiseptic Hand and Body 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	Pro chem, 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 63830-0876-03 (63830087603)

Pricing Information	N/A
NDC Package Code	63830-876-03
Billing NDC	63830087603
Package	350 mL in 1 CARTRIDGE (63830-876-03)
Marketing Start Date	2017-01-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 00214c45-8453-49f5-b3e9-c3602fe96e20 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, fragrance, methylchloroisothiazolinone, methylisothiazolinone, aloe barbadensis, acid red 1

Suds High Foaming Antiseptic Hand & Body Wash 6876

Suds High Foaming Antiseptic Hand & Body Wash

INGREDIENTS AND APPEARANCE

SUDS HIGH FOAMING ANTISEPTIC HAND AND BODY WASH

chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63830-876
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
Packaging
1	NDC:63830-876-06	1 in 1 BOX	01/10/2017
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:63830-876-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
3	NDC:63830-876-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
4	NDC:63830-876-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/10/2017
5	NDC:63830-876-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/10/2017
6	NDC:63830-876-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
7	NDC:63830-876-07	700 mL in 1 BAG; Type 0: Not a Combination Product	01/10/2017
8	NDC:63830-876-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/10/2017
9	NDC:63830-876-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/10/2017
10	NDC:63830-876-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
11	NDC:63830-876-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/10/2017
12	NDC:63830-876-13	800 mL in 1 BAG; Type 0: Not a Combination Product	01/10/2017
13	NDC:63830-876-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
14	NDC:63830-876-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
15	NDC:63830-876-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
16	NDC:63830-876-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/10/2017
17	NDC:63830-876-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	01/10/2017
18	NDC:63830-876-08	1 in 1 BOX	01/10/2017
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC:63830-876-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
20	NDC:63830-876-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/10/2017
21	NDC:63830-876-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	01/10/2017
22	NDC:63830-876-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	01/10/2017
23	NDC:63830-876-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	01/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/10/2017

Labeler - Pro chem, Inc. (061396065)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(63830-876)

Revised: 12/2018

Document Id: f0faa719-7892-40cc-963f-27a971407c55

Set id: 00214c45-8453-49f5-b3e9-c3602fe96e20

Version: 2

Effective Time: 20181227