Ultra Defense Advanced Hand Sanitizer: Package Insert and Label Information

ULTRA DEFENSE ADVANCED HAND SANITIZER- alcohol gel
Republic Nail, 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.

Drug Facts

Active ingredients

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

  • hand sanitizer to help decrease baceteria on the skin
  • when water, soap & towel are not available
  • recommended for repetaed use

Warnings

For external use only.

Flammable, Keep away from fire or flame.

Do not apply around eyes.

Do not use

in ears & mouth

When using this product,

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions

  • pump as needed into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other informaton

  • store at 20° C (68° to 77° F)
  • may discolor fabrics.

Inactive ingredients

water, glycerin, carbomer, Treithanolamine.

Package Labeling:

Label
(click image for full-size original)

Packaging 250mL

250mL
(click image for full-size original)

ULTRA DEFENSE ADVANCED HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77618-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.75 L in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77618-001-01 200 L in 1 DRUM None
2 NDC:77618-001-02 0.25 L in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 05/12/2020
Labeler — Republic Nail, S.A. de C.V. (812914758)

Revised: 06/2020 Republic Nail, S.A. de C.V.

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