OTC Medication Information: P P International Inc. Hand Sanitizer

P P INTERNATIONAL INC. HAND SANITIZER- alcohol gel
Adonis, 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.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. ………. Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

  • For handwashing to decrease microbial contamination on the skin
  • May be reapplied during the day as required.

Warnings

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

Do not Drink.

Do not use

  • In the eyes
  • In case of contact,rinse eyes thoroughly with water.
  • Then contact physician.

When using this product avoid contact with eyes. If contact occurs, rinse rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness devleops and persist for more that 72 hours.

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

Directions

  • Wet hands thoroughly with product
  • Briskly rub hands together until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 20ºC to 250ºC(68ºF-77ºF)
  • May discolor certain fabrics

Inactive ingredients

Glycerin, Water ,Propylene Glycol, Carbomer ,Aminomethyl Propanol,Isopropyl Myristate.

Package Label — Principal Display Panel

CSI 8oz Label
(click image for full-size original)

P P INTERNATIONAL INC. HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77356-989
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPYLENE GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
ISOPROPYL MYRISTATE
AMINOMETHYLPROPANOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77356-989-02 237 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 08/07/2020
Labeler — Adonis, LLC. (116983147)

Revised: 08/2020 Adonis, LLC.

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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