Hand Sanitizer by Pluma Nacional S.a. de C.V. Hand Sanitizer

Drug Details [pdf]

HAND SANITIZER- alcohol spray
Pluma Nacional S.a. 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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Hand Sanitizer

DRUG FACTS

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

USES

For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

WARNINGS

Flammable. Keep away from fire or flame. For external use only hands.

Avoid contact with broken skin.

When using this product

do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help.

DIRECTIONS

Not recommended for infants. Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

OTHER INFORMATION

Do not store above 30°C. may discolor fabrics.

INACTIVE INGREDIENTS

Aqua(water), Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, triethanolamine, Aloe Barbadensis Leaf Extract, Parfum(Fragrance)water.

Package Labeling:30ml

Bottle3 Bottle4

Package Labeling:60ml

Bottle5 Bottle6

HAND SANITIZER
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52381-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52381-002-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	12/30/2022
2	NDC: 52381-002-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	07/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/01/2020	12/30/2022

Labeler - Pluma Nacional S.a. de C.V. (821213352)

Revised: 6/2022

Document Id: e295c540-5a1d-64d3-e053-2995a90ab2f9

Set id: b0796582-d52e-6985-e053-2a95a90ad863

Version: 2

Effective Time: 20220629

Trademark Results [Hand Sanitizer]

Mark Image Registration \| Serial	Company Trademark Application Date
HAND SANITIZER 88958909 not registered Live/Pending	MAISON BLANCHE, LLC 2020-06-10