Panrosa Instant Hand Sanitizer Aloe Vera: Package Insert and Label Information

PANROSA INSTANT HAND SANITIZER ALOE VERA- 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 ingredient

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

  • place enough product into your palms and thoroughly spread on both hands.
  • rub into skin until dry.

Other information

  • store below 110 ℉ (43℃ ).
  • may discolor certain fabrics or surfaces.

Inactive ingredients

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate, FD&C blue No. 1, FD&C yellow No. 5.

Package Labeling:50302-013-10

Bottle5
(click image for full-size original)

Package Labeling:50302-013-60

Bottle6
(click image for full-size original)

PANROSA INSTANT HAND SANITIZER ALOE VERA
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50302-013
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
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50302-013-10 1000 mL in 1 BOTTLE None
2 NDC:50302-013-60 60 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 04/06/2020
Labeler — Panrosa Enterprises, Inc. (859957578)

Revised: 07/2020 Panrosa Enterprises, Inc.

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