Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- isopropyl alcohol liquid
Charta Group Inc dba Permalite 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.

Alcohol 75 % v/v

Antiseptic

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

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

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

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 40 C (104F)

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Hand Sanitizer

Hand Sanitizer
(click image for full-size original)

HAND SANITIZER
hand sanitizer liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74013-444
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74013-444-10 232 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 03/30/2020
Labeler — Charta Group Inc dba Permalite Inc (128512899)
Establishment
Name Address ID/FEI Operations
Charta Group Inc dba Permalite Inc 128512899 manufacture (74013-444)

Revised: 03/2020 Charta Group Inc dba Permalite Inc

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