HAND SANITIZER by EXPORTADORA IN & OUT S DE RL DE CV / ISMAR SOLUCIONES DINAMICAS S DE RL DE CV

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by EXPORTADORA IN & OUT S DE RL DE CV, ISMAR SOLUCIONES DINAMICAS S DE RL DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
EXPORTADORA IN & OUT S DE RL DE CV

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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Active ingredient

benzalkonium chloride v/v 1%

Purposes

Antimicrobial

Uses

hand sanitizer to decrease bacteria on the skin that could cause disease

recommended for repetead use

Warnings

for external use only: hands

flammable, keep away from fire and flame

When using this product

keep out of eyes, do not use in or near the eyes

in case of contact with eyes, flush thorougly with water

avoid contact with broken skin

do not inhale or ingest

When using this product

keep out of eyes, do not use in or near the eyes

in case of contact with eyes, flush thorougly with water

avoid contact with broken skin

do not inhale or ingest

Stop use and ask a doctor if

irritation and redness develo

condition persists for more than 72 hours

Keep out of reach of children

if swallowed, get medical help or contact a posion control center right away

Directions

put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

for children under 6 years of age should be supervised when using germ killa

not recommended for infants

Other information

store below 105 F (40C)

may discolor certain fabrics

harmful to wood finishes and plastics

Inactive ingredients

CMC, Glycerine, Water, Orange oil

Principal Display

Efficiently kills 99.99% of most illness causing germs

hand sanitizer gel

leaves hands soft

contain moisturizers

paraben free

phtalate free

formaldehyde donor free

250 ml

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77210-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
ORANGE OIL (UNII: AKN3KSD11B)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77210-0014-1	250 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2020	09/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/07/2020	09/08/2020

Labeler - EXPORTADORA IN & OUT S DE RL DE CV (951577298)

Registrant - ISMAR SOLUCIONES DINAMICAS S DE RL DE CV (951577818)

Establishment
Name	Address	ID/FEI	Business Operations
ISMAR SOLUCIONES DINAMICAS S DE RL DE CV		951577818	pack(77210-0014) , label(77210-0014) , manufacture(77210-0014)

Revised: 9/2020

Document Id: aed00280-ec65-42a9-e053-2995a90a6e35

34390-5

Set id: a9e1d9e0-91cf-0ccb-e053-2a95a90aa7d4

Version: 2

Effective Time: 20200908