HAND SANITIZER- ethyl alcohol gel 
CARAVAN CANOPY INT'L 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.

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Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 71% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

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

Recommended for repeated use

Warnings

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

Do not use

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.

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

Other information

Inactive ingredients

Water, Glycerin, Humi-fulvate, Fragrance, Carbomer, Arginine, Sodium Hyaluronate, Calendula Officinalis Flower Extract, Carica Papaya (Papaya) Fruit Extract, Olea Europaea (Olive) Leaf Extract

Package Label - Principal Display Panel

500 ml label500 ml NDC: 74464-001-10

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74464-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL71 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208) 0.3 mL  in 100 mL
ARGININE (UNII: 94ZLA3W45F)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
WATER (UNII: 059QF0KO0R)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.4 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74464-001-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/03/2020
Labeler - CARAVAN CANOPY INT'L INC. (800224003)
Registrant - CARAVAN CANOPY INT'L INC. (800224003)
Establishment
NameAddressID/FEIBusiness Operations
CARAVAN CANOPY INT'L INC.800224003manufacture(74464-001)

Revised: 11/2020
Document Id: b21f67a0-a439-5f57-e053-2995a90a1f1b
Set id: a26540e0-d4e2-cfbc-e053-2a95a90a402e
Version: 2
Effective Time: 20201117
 
CARAVAN CANOPY INT'L INC.