PRANAROM AROMAFORCE ALCOHOL ANTISEPTIC- alcohol liquid 
Veriditas Botanicals LLC

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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Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Helps reduce bacteria on skin. Recommended for repeated use.

Warnings

For external use only.

Other information

  • Flammable. Keep away from fire, sparks, and sources of ignition.
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

When using this product Keep out of eyes. In case of contact with eyes, fush thoroughly with water. Avoid contact with broken skin.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry. For children under 6, use adult
supervision. Not recommended for infants.

Inactive ingredients

Rosa x damascena (Rose) Flower Water,* Glycerin,* Ricinus communis (Castor) Seed Oil,* Citrus aurantium bergamia (Bergamot) Peel Oil,* Cedrus atlantica (Cedarwood) Bark Oil,* Mentha x piperita (Peppermint) Oil,* Melaleuca alternifolia (Tea Tree) Oil.* *CERTIFIED ORGANIC

Package Label - Principal Display Panel

PRANARÕM

HAND SANITIZER

Moisturizing Formula

Non-Sterile Solution

AROMAFORCE(TM)

Alcohol antiseptic 70% topical solution

xx fl. oz | xx ml

PRANAROM SCIENTIFIC AROMATHERAPY

Minneapolis, MN 55427 | pranarom.us

Certified Organic

by ECOCERT ICO.

Label 1oz size

4 Oz Size Pranarom Hand Sanitizer

PRANAROM AROMAFORCE ALCOHOL ANTISEPTIC 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78596-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CASTOR OIL (UNII: D5340Y2I9G)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
TEA TREE OIL (UNII: VIF565UC2G)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
WATER (UNII: 059QF0KO0R)  
ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78596-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
2NDC:78596-001-02120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/12/2020
Labeler - Veriditas Botanicals LLC (174766845)
Registrant - Veriditas Botanicals LLC (174766845)
Establishment
NameAddressID/FEIBusiness Operations
Veriditas Botanicals LLC174766845manufacture(78596-001) , analysis(78596-001) , label(78596-001) , pack(78596-001) , relabel(78596-001) , repack(78596-001)

Revised: 6/2020
Document Id: a70b9c10-1bf0-84ca-e053-2995a90a9ed2
Set id: a70babce-873b-eb0f-e053-2995a90ad092
Version: 1
Effective Time: 20200601
 
Veriditas Botanicals LLC