Drug Labeling and Warnings

Drug Details

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CLEAR LAKES PRODUCTS HAND SANITIZER- hand sanitizer 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.

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Active Ingredient

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 TypeHUMAN OTC DRUGItem Code (Source)NDC: 73749-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 L  in 1 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73749-101-593.758 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
2NDC: 73749-101-391.040875 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
3NDC: 73749-101-991040.875 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
4NDC: 73749-101-290.473176 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34403/18/2020
Labeler - Clear Lakes Products, LLC (127464365)
Establishment
NameAddressID/FEIBusiness Operations
Clear Lakes Products, LLC127464365manufacture(73749-101)

Revised: 3/2020
 
Clear Lakes Products, LLC


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