MINI CARE HAND SANITIZER ALCOHOL- alcohol gel

MINI CARE Hand Sanitizer Alcohol by

Drug Labeling and Warnings

MINI CARE Hand Sanitizer Alcohol by is a Otc medication manufactured, distributed, or labeled by Harmonia de Venezuela CA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

Use

For hand sanitizing to decrease bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external uses only.

When using this products avoid contact of eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if conditions persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direction

Apply a small amount into palm of hands and rub hands together briskly until dry.

Inactive ingredients

Water, glycerin, triethanolamine, carbomer, fragrance, FD&C Blue No. 1, FD&C Yellow No. 5

Package Label - Principal Display Panel

1 mL

Pack of 100 (1 mL)

28 mL

Pack of 4 (28 mL)

100 mL

19 Litre

208 Litre 

3800 mL

INGREDIENTS AND APPEARANCE

MINI CARE HAND SANITIZER ALCOHOL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73360-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73360-004-01	28 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
2	NDC: 73360-004-02	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
3	NDC: 73360-004-03	1 mL in 1 POUCH; Type 0: Not a Combination Product	08/01/2020
4	NDC: 73360-004-04	19000 mL in 1 PAIL; Type 0: Not a Combination Product	08/01/2020
5	NDC: 73360-004-05	208000 mL in 1 DRUM; Type 0: Not a Combination Product	08/01/2020
6	NDC: 73360-004-06	3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/01/2020
7	NDC: 73360-004-07	4 in 1 CARTON	08/01/2020
7		28 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8	NDC: 73360-004-08	100 in 1 CARTON	08/01/2020
8		1 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020

Labeler - Harmonia de Venezuela CA (817307290)

Establishment
Name	Address	ID/FEI	Business Operations
Harmonia de Venezuela CA		817307290	manufacture(73360-004)