HAND SANITIZER GEL- hand sanitizer gel gel 
New Directions Aromatics 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 Gel

Alcohol 65%. Purpose: Antiseptic

Antiseptic, Hand Sanitizer

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.

This product contains a chemical that is currently listed under California's Proposition 65.

-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.

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.

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Purified Water, Glycerin, Polyquaternium-37, Aloe Barbadensis Leaf Juice

Label_Hand Sanitizer Gel 473 mL

NDC 473 mL: 74179-800-01

Label_Hand Sanitizer Gel 200L

Label_Hand Sanitizer Gel Bulk Drug Facts

NDC 200L: 74179-800-02

Label_Hand Sanitizer Gel 1000L (264 gal)

NDC 1000L: 74179-800-04

Label_Hand Sanitizer Gel 60 mL

NDC 60 mL: 74179-800-05

Label_Hand Sanitizer Gel 240 mL

NDC 240 mL: 74179-800-06

HAND SANITIZER GEL 
hand sanitizer gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74179-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.65 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 0.33199 mL  in 1 mL
POLYQUATERNIUM-37 (25000 MPA.S) (UNII: 31L31U8285) 0.008 mL  in 1 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.00001 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.01 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74179-800-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/16/2020
2NDC:74179-800-02200000 mL in 1 DRUM; Type 0: Not a Combination Product04/16/2020
3NDC:74179-800-041000000 mL in 1 TANK; Type 0: Not a Combination Product05/12/2020
4NDC:74179-800-0560 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
5NDC:74179-800-06240 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/16/2020
Labeler - New Directions Aromatics Inc. (200570278)
Registrant - New Directions Aromatics Inc. (200570278)
Establishment
NameAddressID/FEIBusiness Operations
New Directions Aromatics Inc.200570278manufacture(74179-800)

Revised: 7/2020
Document Id: aaf30840-d05c-79a7-e053-2a95a90aeac9
Set id: a36ad864-f131-8023-e053-2995a90a7727
Version: 6
Effective Time: 20200721
 
New Directions Aromatics Inc.