Clear Lakes Products Hand Sanitizer: Package Insert and Label Information

CLEAR LAKES PRODUCTS HAND SANITIZER- isopropyl alcohol gel
Clear Lakes Products, 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.

Isopropyl Alcohol 70%

Purpose

Antimicrobial

Uses

  • For hand sanitizing to decrease bacteria on the skin
  • Recommended for repeated use

Warnings

  • For external use only.
  • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
  • Stop use and ask doctor if irritation or redness develops, or if condition persists for more than 72 hours.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.

• For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask doctor if irritation or redness develops, or if condition persists for more than 72 hours.

• Keep out of reach of children.

If swallowed , get medical help or contact a Poison Control Center immediately.

Directions

  • Pump a small amount into palm.
  • Rub thoroughly over all surfaces of both hands.
  • Rub hands together briskly until dry.

Inactive ingredients

Water, Hydroxyethylcellulose

Drug Facts

1 gallon label

CLEAR LAKES PRODUCTS HAND SANITIZER
hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73749-101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 L in 1 L
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73749-101-59 3.758 L in 1 BOTTLE, PLASTIC None
2 NDC:73749-101-39 1.040875 L in 1 BOTTLE, PLASTIC None
3 NDC:73749-101-99 1040.875 L in 1 BOTTLE, PLASTIC None
4 NDC:73749-101-29 0.473176 L in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/18/2020
Labeler — Clear Lakes Products, LLC (127464365)
Establishment
Name Address ID/FEI Operations
Clear Lakes Products, LLC 127464365 manufacture (73749-101)

Revised: 04/2020 Clear Lakes Products, LLC

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