TOPCARE ADVANCED HAND SANITIZER ALOE- ethyl alcohol liquid

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

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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:
36800-995-02, 36800-995-08

TOPCARE ADVANCED HAND SANITIZER ALOE- 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.

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Drug Facts

Active ingredient

Ethyl Alchol 70%

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.

Sto 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, Aloe Barbadensis Leaf Juice, Propylene Glycol, Glycerin, Isopropyl

Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum),

Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090).

Label copy

TOPCARE ADVANCED HAND SANITIZER ALOE

ethyl alcohol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:36 8 0 0 -9 9 5

Route of Administration

TOPICAL

TopCo Associates LLC

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

70 0 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)

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

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

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

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

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

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:36 8 0 0 -9 9 5-

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 5-

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 5)

Revised: 8/2019

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