Purity Farmapiel Hand Sanitizer 70% Alcohol

Purity Farmapiel Hand Sanitizer 70% Alcohol by

Drug Labeling and Warnings

Purity Farmapiel Hand Sanitizer 70% Alcohol by is a Otc medication manufactured, distributed, or labeled by Centro Internacional de Cosmiatría S.A.P.I. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURITY FARMAPIEL HAND SANITIZER 70% ALCOHOL- alcohol hand sanitizer gel 
Centro Internacional de Cosmiatría S.A.P.I. de C.V.

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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Purity Farmapiel Hand Sanitizer 70% Alcohol

Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Uses

To decrease bacteria on the skin when water, soap & towel are not available - Recommended for repeated use.

Warnings

For external use only.

Flammable - Keep away from fire or flame.

When using this product

keep out of eyes. In case of contact with eyes, rinse thoroughly with water. Do not use on broken or irritated skin.

Stop use and ask a doctor if

Irritation or redness develop and last more than 72 hours.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other information

• Do not store above 105°F (40°C)
• May discolor certain wood surfaces

Inactive Ingredients:

water, glycerin, aloe barbadensis leaf juice, carbomer, triethanolamine.

59.14 mL (2oz) NDC: 77229-002-01

118.29mL (4oz) NDC: 77229-002-02

236.58mL (8 oz) NDC: 77229-002-03

473.17mL (16oz) NDC: 77229-002-04

946.35mL (32oz) NDC: 77229-002-05

59.14mL 2Oz NDC: 77229-002-06

PURITY FARMAPIEL HAND SANITIZER 70% ALCOHOL 
alcohol hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77229-002
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
TROLAMINE (UNII: 9O3K93S3TK)	0.2 g  in 100 mL
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)	0.2 g  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.5 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 mL
WATER (UNII: 059QF0KO0R)	26.8 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77229-002-01	59.14 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/03/2020	09/22/2020
2	NDC: 77229-002-02	118.29 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2020	09/22/2020
3	NDC: 77229-002-03	236.58 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2020	09/22/2020
4	NDC: 77229-002-04	473.17 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2020	09/22/2020
5	NDC: 77229-002-05	946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2020	09/22/2020
6	NDC: 77229-002-06	59.14 mL in 1 TUBE; Type 0: Not a Combination Product	08/21/2020	09/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/03/2020	09/22/2020

Labeler - Centro Internacional de Cosmiatría S.A.P.I. de C.V. (814124954)

Registrant - Centro Internacional de Cosmiatría S.A.P.I. de C.V. (814124954)

Establishment
Name	Address	ID/FEI	Business Operations
Centro Internacional de Cosmiatría S.A.P.I. de C.V.		814124954	manufacture(77229-002)

Revised: 7/2021

Document Id: c74261a0-62da-5226-e053-2995a90a9275

34390-5

Set id: a8d7486c-cd2d-249e-e053-2995a90a3a5d

Version: 3

Effective Time: 20210716

 

Centro Inter