TOPCARE PREBIOTIC HAND SANITIZER- ethyl alcohol liquid

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
TopCo Associates LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
to help reduce bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
36800-996-02, 36800-996-08

TOPCARE PREBIOTIC HAND SANITIZER- ethyl alcohol liquid

TopCo Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient

Ethyl Alcohol 65%

Purpos e

Antiseptic

Us es

to help reduce bacteria on the skin

Warnings

For external use only

Flammable

Keep away from source of heat or fire

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and lasts

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. 1-

800-222-1222

Directions

put enough hand sanitizer in your palm to cover hands and rub hands together until dry.

children under 6 years should be supervised when using this product.

Other information

store at a temperature below 110°F (43°C)

may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf

Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance

(Parfum).

Label copy

TOPCARE PREBIOTIC HAND SANITIZER

ethyl alcohol liquid

Product Information

TopCo Associates LLC

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -9 9 6

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 50 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

.ALPHA.-GLUCAN O LIGO SACCHARIDE (UNII: S9 56 58 MI3W)

GLYCERIN (UNII: PDC6 A3C0 OX)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:36 8 0 0 -9 9 6 -

236 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /20 /20 19

2

NDC:36 8 0 0 -9 9 6 -

59 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 8 /20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 8 /20 /20 19

Labeler -

T opCo Associates LLC (006935977)

Registrant -

Apollo Health and Beauty Care Inc. (201901209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo llo Health and Beauty Care Inc.

20 19 0 120 9

ma nufa c ture (36 8 0 0 -9 9 6 )

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information