ALOE VERA HAND SANITIZER W/FRAGRANCE- alcohol gel 
L.O.D.C. Group, Ltd.

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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Purpose

Hand sanitizer to help reduce bacteria on the skin

Use

hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from heat or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts..

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 appears and lasts.

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

Directions

Other information

Inactive ingredients

Aloe Vera Leaf Juice (Organic), Ammonium Polyacryloyl Dimethyl Taurate, Caprylyl Glycol, Fragrance, Glycerin, Isopropyl Myristate, Tocopheryl Acetate (Vitamin E), Water (Aqua)

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label - Principal Display Panel

Principal Display Panel 2oz

8oz

16oz

128 oz

ALOE VERA HAND SANITIZER W/FRAGRANCE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79949-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL34.6231 g  in 51.3338 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.37263 g  in 51.3338 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 8.87207 g  in 51.3338 g
WATER (UNII: 059QF0KO0R) 6.38414 g  in 51.3338 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.2703 g  in 51.3338 g
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) 0.64167 g  in 51.3338 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 0.12053 g  in 51.3338 g
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) 0.02819 g  in 51.3338 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79949-001-0151.3338 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
2NDC:79949-001-033285.363 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/25/2020
3NDC:79949-001-02205.3352 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
4NDC:79949-001-04410.6704 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/25/2020
Labeler - L.O.D.C. Group, Ltd. (034768961)
Registrant - Lily of the Desert (604850123)
Establishment
NameAddressID/FEIBusiness Operations
L.O.D.C. Group, Ltd.034768961manufacture(79949-001)

Revised: 7/2021
Document Id: c70404af-23af-8c33-e053-2995a90a1377
Set id: a4730626-3124-662d-e053-2a95a90a0c1f
Version: 2
Effective Time: 20210713
 
L.O.D.C. Group, Ltd.