Sani-Care by Pro Chem, Inc. / ABC Compounding Co., Inc. SANI-CARE- alcohol gel

Sani-Care by

Drug Labeling and Warnings

Sani-Care by is a Otc medication manufactured, distributed, or labeled by Pro Chem, Inc., ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Sani-Care 6605

Sani-Care

INGREDIENTS AND APPEARANCE

SANI-CARE 
alcohol gel

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63830-221-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2003
2	NDC: 63830-221-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2003
3	NDC: 63830-221-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2003

Labeler - Pro Chem, Inc. (061396065)

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

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