EcoSoft Hand Sanitizer by Organic Beauty Unlimited LLC / Organic Beauty Unlimited llC

EcoSoft Hand Sanitizer by

Drug Labeling and Warnings

EcoSoft Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Organic Beauty Unlimited LLC, Organic Beauty Unlimited llC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECOSOFT HAND SANITIZER- benzalkonium chloride lotion 
Organic Beauty Unlimited 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

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Inactive Ingredients

deionized water, glycerin, sunflower oil, shea butter, avocado oil, aloe vera gel, lecithin, jojoba oil, carbomer, almond oil, grape seed oil, pomegranate, raspberry, grapefruit, eucalyptus oil

Directions

Apply enough product in palm of hand to cover hands completely. Gently rub and massage into hands until dry. Children under 6 years of age should have adult supervision when using this product.

Warnings

For external use only. Do not use in the eyes. In case of eye contact flush eyes with water.

Stop use and ask a doctor if irritation and redness develop

Warnings

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Uses

Hand sanitizer to help reduce bacteria on the skin. Repeated use recommended

Other Information

Store under 105°F

60 mL NDC: 79605-022-02 60 ml label

250 mL NDC: 79605-022-08 250 mL label

473 mL NDC: 79605-022-16 473 mL label

947 mL NDC: 79605-022-32 947 mL label

1.89 L NDC: 79605-022-64 1.89 L label

3.78 L NDC: 79605-022-50 3.78 L label

208L NDC: 79605-022-55 208 L label

1041 L NDC: 79605-022-75 1041 L label

ECOSOFT HAND SANITIZER 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79605-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
JOJOBA OIL (UNII: 724GKU717M)  
GRAPEFRUIT (UNII: O82C39RR8C)  
POMEGRANATE (UNII: 56687D1Z4D)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
ALMOND OIL (UNII: 66YXD4DKO9)  
RASPBERRY (UNII: 4N14V5R27W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79605-022-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
2NDC: 79605-022-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
3NDC: 79605-022-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
4NDC: 79605-022-32947 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
5NDC: 79605-022-503780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
6NDC: 79605-022-55208000 mL in 1 DRUM; Type 0: Not a Combination Product07/13/2020
7NDC: 79605-022-751041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product07/13/2020
8NDC: 79605-022-641890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/13/202004/30/2021
Labeler - Organic Beauty Unlimited LLC (956059088)

Revised: 1/2022
Document Id: d57bdc5b-1927-3611-e053-2995a90a18f5
Set id: a9ccd281-2728-541c-e053-2a95a90a8287
Version: 3
Effective Time: 20220113