MANI SPA GUARD ANTISEPTIC HAND SANITIZER- alcohol solution

MANI SPA GUARD ANTISEPTIC HAND SANITIZER by

Drug Labeling and Warnings

MANI SPA GUARD ANTISEPTIC HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Pedisource. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Alcohol 80% v/v

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin
recommended for repeated use
for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use
in children less than 2 months of age
on open skin wounds

When using this product do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if
irritation and redness develop
condition persists for more than 72 hours

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

Directions

wet hands thoroughly with product and allow to dry without wiping
supervise children under 6 years of age when using this product to avoid swallowing

Other information

  store between 15-30°C (59-86°F)
  avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, hydrogen peroxide, water

Questions?

+1-856-320-6927

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

MADE IN *** THE USA

TOPICAL SOLUTION

NON-STERILE SOLUTION

Manufactured by: PediSource LLC, Cinnaminson, NJ, 08077

www.ManiSpaGuard.com

Packaging

INGREDIENTS AND APPEARANCE

MANI SPA GUARD ANTISEPTIC HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77591-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77591-001-05	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/28/2020
2	NDC: 77591-001-06	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/28/2020
3	NDC: 77591-001-07	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/28/2020

Labeler - Pedisource (023429060)

Establishment
Name	Address	ID/FEI	Business Operations
Pedisource		023429060	manufacture(77591-001)