INFINITE ALOE ALL-IN-ONE SKIN CARE- allantoin, colloidal oatmeal lotion 
Economical Solutions, Inc. (DBA INFINITE ALOE)

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 INGREDIENTS

ALLANTOIN .5%

COLLOIDAL OATMEAL .07%

PURPOSE

SKIN PROTECTANT

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to

  • Eczema
  • Rashes
  • Poison ivy, oak, or sumac
  • Insect bites

Temporarily protects minor:

  • cuts
  • scrapes
  • burns
  • Helps prevent and temporarily protects and helps relieve chafed,chapped or cracked skin.
  • Helps prevent and protect from the drying effects of wind and cold weather.

Warnings For external use only. When using this product do not get into eyes. Stop using this product and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or if they clear up and occur again within a few days.

Keep out of reach of children. If product is swallowed, get medical help or call a Poison Control Center immediately.

DIRECTIONS

APPLY AS NEEDED

Inactive ingredients Aloe Barbadensis leaf juice (Organic Aloe Vera), Deionized water (Aqua), Glycerin (Plant Source), Isopropyl Palmitate, Cetyl Alcohol, Hyaluronic Acid, Glyceryl Stearate, Cetyl Lactate, Soluble Collagen, Dimethyl Sulfone (MSM), Thioctic Acid (Alpha Lipoic Acid), Zea Mays (Organic Corn) Oil, Tocopheryl Acetate (Vitamin E), Ubiquinone (Coenzyme Q10), Retinyl Palmitate (Vitamin A) (and) Cholecalciferol
(Vitamin D), Hexanoyl Dipeptide-3 Norleucine Acetate (and) Lecithin, Dimethyl MEA (DMAE), Vitis Vinifera (Grape) Seed Oil, Rosa Canina (Rose Hips) Fruit Oil, Prunus Armeniaca (Apricot) Kernel Oil, Yucca Schidigera Extract, Ascorbic Acid (Vitamin C), Thiamine HCL (Vitamin B1 Hydrochloride), Phytonadione (Vitamin K1), Symphytum Officinale (Comfrey) Leaf Extract, Panax Ginseng Root Extract, Foeniculum Vulgare
(Fennel) Seed Extract, Chamomilla Recutita (Chamomile) Flower Extract, Camellia Oleifera (Green Tea) Leaf Extract, Calendula Officinalis (Marigold) Flower Extract, Citrus Grandis (Grapefruit) Fruit Extract, Usnea Barbata (Lichen) Extract, Niacin (Vitamin B3), Methyl Gluceth 20, Polysorbate 80, DMDM Hydantoin (and) Iodopropynyl Butylcarbamate, Disodium EDTA, BHT, Carbomer, Triethanolamine, Hydrolyzed  Glycosaminoglycans.

Questions? Call 1-888-LUV-ALOE (+1 323 906-2880 outside USA) or visit www.InfiniteAloe.com

image description

INFINITE ALOE ALL-IN-ONE SKIN CARE 
allantoin, colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69069-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.07 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
HYALURONIC ACID (UNII: S270N0TRQY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETYL LACTATE (UNII: A7EVH2RK4O)  
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
THIOCTIC ACID, (+)- (UNII: VLL71EBS9Z)  
CORN OIL (UNII: 8470G57WFM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
UBIQUINONE Q2 (UNII: I7T5V2W47R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
HEXANOYL DIPEPTIDE-3 NORLEUCINE ACETATE (UNII: P8A02Z93M6)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
DEANOL (UNII: 2N6K9DRA24)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
THIAMINE HYDROCHLORIDE (UNII: M572600E5P)  
PHYTONADIONE (UNII: A034SE7857)  
COMFREY LEAF (UNII: DG4F8T839X)  
PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)  
FENNEL SEED (UNII: G3QC02NIE6)  
CHAMOMILE (UNII: FGL3685T2X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GRAPEFRUIT JUICE (UNII: JQ9EK2H6BG)  
USNEA BARBATA (UNII: D6DVA9TCAP)  
NIACIN (UNII: 2679MF687A)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER 934 (UNII: Z135WT9208)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69069-101-18238 mL in 1 JAR; Type 0: Not a Combination Product07/01/201405/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/201405/26/2017
Labeler - Economical Solutions, Inc. (DBA INFINITE ALOE) (008046445)

Revised: 5/2017
Document Id: 2505c49b-04d8-4121-9f97-da22a07abbc1
Set id: c8fcd1b5-b271-450d-ad92-23f98ae9606c
Version: 2
Effective Time: 20170526
 
Economical Solutions, Inc. (DBA INFINITE ALOE)