Primest Hand Sanitizer Non Sterile Alcohol 70: Package Insert and Label Information

PRIMEST HAND SANITIZER NON STERILE ALCOHOL 70- alcohol gel
Prime Lab, 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.

Drug Facts

Active ingredient[s]

Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

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.

Directions

  • Place enough product on hands to cover all surfaces. Rubs 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

glycerin, hydrogen peroxide, purified water USP

Package Labeling: 3780 ml

Bottle5
(click image for full-size original)

Package Labeling:236 ml

Label
(click image for full-size original)

PRIMEST HAND SANITIZER NON STERILE ALCOHOL 70
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79937-003
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
GLYCERIN
HYDROGEN PEROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79937-003-01 3780 mL in 1 BOTTLE None
2 NDC:79937-003-02 236 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 07/15/2020
Labeler — Prime Lab, LLC (117553548)

Revised: 10/2020 Prime Lab, LLC

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