OTC Medication Information: PANROSA Instant Hand Sanitizer

PANROSA INSTANT HAND SANITIZER- alcohol gel
PANROSA ENTERPRISES, INC.

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 70% v/v

Purpose

Antiseptic

Uses

  • hand sanitizer to help 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.

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 need into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other information

  • store at 20ºC (68ºF) to 77ºF)
  • may discolor fabrics.

Inactive ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

Package Labeling:

Label2

PANROSA INSTANT HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50302-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
GLYCERIN
PROPYLENE GLYCOL
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50302-007-00 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/23/2020
Labeler — PANROSA ENTERPRISES, INC. (859957578)

Revised: 04/2020 PANROSA ENTERPRISES, INC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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