Panrosa Antibacterial Hand Soap -Aloe Vera

Panrosa Antibacterial Hand Aloe Vera by

Drug Labeling and Warnings

Panrosa Antibacterial Hand Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Panrosa Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PANROSA ANTIBACTERIAL HAND 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.

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Panrosa Antibacterial Hand Soap -Aloe Vera

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.

Warnigns

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

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:

Label4

PANROSA ANTIBACTERIAL HAND ALOE VERA 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50302-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50302-018-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/202008/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/03/202008/03/2020
Labeler - Panrosa Enterprises, Inc. (859957578)

Revised: 8/2020
Document Id: ad1359c7-e95a-3b30-e053-2a95a90a7856
Set id: 57a3fc9d-659b-4234-a5e1-a6656053f014
Version: 2
Effective Time: 20200817