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NDC 63830-0221-21 Sani-Care 0.7 mL/mL Details

Sani-Care 0.7 mL/mL

Sani-Care is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Pro Chem, Inc.. The primary component is ALCOHOL.

Product Information

NDC	63830-0221
Product ID	63830-221_785f1a4b-8d07-4446-8e9e-ca93535e046a
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	Sani-Care
Proprietary Name Suffix	n/a
Non-Proprietary Name	ALCOHOL
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.7
Active Ingredient Units	mL/mL
Substance Name	ALCOHOL
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 63830-0221-21 (63830022121)

Pricing Information	N/A
NDC Package Code	63830-221-21
Billing NDC	63830022121
Package	2.5 mL in 1 DOSE PACK (63830-221-21)
Marketing Start Date	2020-07-16
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0794f32d-f9bd-460c-ba71-1bf9f68c109a Details

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

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 thoroughly with product and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, DMDM hydantoin, diisopropylamine, carbomer, propylene glycol, tocopheryl acetate, aloe barbadensis

Sani-Care 6605

Sani-Care doze pack label

INGREDIENTS AND APPEARANCE

SANI-CARE

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63830-221
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63830-221-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2020
2	NDC:63830-221-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2020
3	NDC:63830-221-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2020
4	NDC:63830-221-21	2.5 mL in 1 DOSE PACK; Type 0: Not a Combination Product	07/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/16/2020

Labeler - Pro Chem, Inc. (061396065)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(63830-221)

Revised: 7/2020

Document Id: 785f1a4b-8d07-4446-8e9e-ca93535e046a

Set id: 0794f32d-f9bd-460c-ba71-1bf9f68c109a

Version: 6

Effective Time: 20200716