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Recens Ultra

Certus Medical, Inc.
ABC Compounding Co., Inc.

Recens Ultra 6365 Drug Facts and Label


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol,  Glyceryl Stearate, Glycerin, Ceteareth-12, Cetyl Palmitate,  Carbomer, Diisopropylamine, Sodium Styrene/PEG-10 Maleate/Nonoxynol-10 Maleate/Acrylates Copolymer, Methylparaben, Propylparaben, fragrance,  Tocopheryl Acetate, Aloe Barbadensis

Recens Ultra 6365 1000 ml

6365M5PM.jpg  Recens Ultra  1000 ml  Recens Ultra

Recens Ultra

ALCOHOL LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:75990-365
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ALCOHOL ALCOHOL 0.7 mL

Inactive Ingredients

Ingredient Name Strength
water
CARBOMER 1342
PROPYLPARABEN
Aloe Vera Leaf
.ALPHA.-TOCOPHEROL ACETATE, DL-
METHYLPARABEN
DIISOPROPYLAMINE
Cetearyl Isononanoate
CETEARETH-12
CETOSTEARYL ALCOHOL
GLYCERYL MONOSTEARATE
cetyl palmitate
GLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 800 in 1 BAG
2 NDC:75990-365-17 532 in 1 BOTTLE, PLASTIC
3 NDC:75990-365-24 118 in 1 BOTTLE, PLASTIC
4 NDC:75990-365-01 1200 in 1 CARTRIDGE
5 NDC:75990-365-03 350 in 1 CARTRIDGE
6 NDC:75990-365-05 540 in 1 BOTTLE, PLASTIC
7 NDC:75990-365-07 700 in 1 BAG
8 NDC:75990-365-09 2000 in 1 CARTRIDGE
9 NDC:75990-365-10 1000 in 1 CARTRIDGE
10 NDC:75990-365-11 1000 in 1 BOTTLE, PLASTIC
11 NDC:75990-365-12 1000 in 1 BAG
12 NDC:75990-365-13 800 in 1 BAG
13 NDC:75990-365-14 3785 in 1 BOTTLE, PLASTIC
14 NDC:75990-365-15 946 in 1 BOTTLE, PLASTIC
15 NDC:75990-365-28 149 in 1 BOTTLE, PLASTIC
16 NDC:75990-365-27 800 in 1 CARTRIDGE
17 NDC:75990-365-55 208200 in 1 DRUM
18 1000 in 1 BAG
19 NDC:75990-365-08 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partE part333E 2011-07-28


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