Plumeria Hand Sanitizer: Package Insert and Label Information

PLUMERIA HAND SANITIZER- alcohol gel
Intellectual AG 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.

Alcohol 63% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aloe vera, hydrogen peroxide, purified water USP, plumeria essential oil

Package Label — Principal Display Panel

100 mL NDC: 74190-100-01

Front
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Back
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PLUMERIA HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74190-100
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 74.13 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF 24.75 mL in 100 mL
HYDROGEN PEROXIDE 0.125 mL in 100 mL
WATER 1 mL in 100 mL
PLUMERIA ALBA FLOWER 1 mL in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74190-100-01 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/30/2020
Labeler — Intellectual AG LLC (084442238)
Establishment
Name Address ID/FEI Operations
Intellectual AG LLC 084442238 manufacture (74190-100)

Revised: 01/2022 Intellectual AG LLC

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