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NDC 68642-0876-19 Healthy Hands Aloe Antiseptic Hand and Body Wash 3 mg/mL Details

Healthy Hands Aloe Antiseptic Hand and Body Wash 3 mg/mL

Healthy Hands Aloe Antiseptic Hand and Body Wash is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Omega Industrial Supply, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	68642-0876
Product ID	68642-876_7245a12c-468b-4373-b7ef-28ffd13eef81
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	Healthy Hands Aloe 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	Omega Industrial Supply, 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 68642-0876-19 (68642087619)

Pricing Information	N/A
NDC Package Code	68642-876-19
Billing NDC	68642087619
Package	18900 mL in 1 CONTAINER (68642-876-19)
Marketing Start Date	2017-04-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2bd927d5-0357-4861-a94e-285cab99a7c5 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

Healthy Hands Aloe Antiseptic Hand and Body Wash 6876 Label

INGREDIENTS AND APPEARANCE

HEALTHY HANDS ALOE ANTISEPTIC HAND AND BODY WASH

chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68642-876
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:68642-876-06	1 in 1 BOX	04/21/2017
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:68642-876-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
3	NDC:68642-876-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
4	NDC:68642-876-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/21/2017
5	NDC:68642-876-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/21/2017
6	NDC:68642-876-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
7	NDC:68642-876-07	700 mL in 1 BAG; Type 0: Not a Combination Product	04/21/2017
8	NDC:68642-876-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/21/2017
9	NDC:68642-876-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/21/2017
10	NDC:68642-876-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
11	NDC:68642-876-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/21/2017
12	NDC:68642-876-13	800 mL in 1 BAG; Type 0: Not a Combination Product	04/21/2017
13	NDC:68642-876-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
14	NDC:68642-876-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
15	NDC:68642-876-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
16	NDC:68642-876-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	04/21/2017
17	NDC:68642-876-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	04/21/2017
18	NDC:68642-876-08	1 in 1 BOX	04/21/2017
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC:68642-876-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
20	NDC:68642-876-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/21/2017
21	NDC:68642-876-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/21/2017
22	NDC:68642-876-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	04/21/2017
23	NDC:68642-876-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	04/21/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/21/2017

Labeler - Omega Industrial Supply, Inc. (007533706)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(68642-876)

Revised: 12/2018

Document Id: 7245a12c-468b-4373-b7ef-28ffd13eef81

Set id: 2bd927d5-0357-4861-a94e-285cab99a7c5

Version: 3

Effective Time: 20181228