Recens Gel by Certus Medical, Inc. / ABC Compounding Co., Inc. RECENS GEL- alcohol gel

Recens Gel by

Drug Labeling and Warnings

Recens Gel by is a Otc medication manufactured, distributed, or labeled by Certus Medical, 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, triethanolamine, carbomer, propylene glycol, tocopheryl acetate, aloe barbadensis, dmdm hydantoin, fragrance

Recens Gel 6547 Drug Facts and Label

Recens Gel 6547 Label

INGREDIENTS AND APPEARANCE

RECENS GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75990-547
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75990-547-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
2	NDC: 75990-547-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
3	NDC: 75990-547-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	05/18/2020
4	NDC: 75990-547-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
5	NDC: 75990-547-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
6	NDC: 75990-547-13	800 mL in 1 BAG; Type 0: Not a Combination Product	05/18/2020
7	NDC: 75990-547-47	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
8	NDC: 75990-547-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020
9	NDC: 75990-547-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	05/18/2020
10	NDC: 75990-547-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/18/2020

Labeler - Certus Medical, Inc. (966433653)

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

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(75990-547)