Desert Harvest RELEVEUM

Active Ingredients:

Lidocaine, USP 4%

Purpose:

External analgesic

Uses:

For the temporary relief of pain associated with minor burns.

Warnings:

For external use only. Do not use on open wounds. Avoid contact with eyes.

Keep out of reach of children.

Stop use and ask a doctor if:

condition worsens
a rash or irritation develops

Directions:

Apply a thin, even later up to 4 times daily or as directed by a qualified healthcare practitioner. Wash hands after use. Adults and children 2 years of age and older:Children under 2 years of age and pregnant/breastfeeding women, consult a doctor.

Inactive ingredients

Deionized Water, Certified Organic Aloe Barbadensis Leaf Juice, Glyceryl Stearate (Natural Skin Lubricant), Stearic Acid (Plant-based Fatty Acid), Cartharnus Tinctorius (Safflower) Seed Oil, Rosa Canina (Rosehips) Fruit Oil, Sodium Ascorbyl Phosphate (Vitamin C), Salvia Sin-ensis (Chia) Seed Oil, Vegetable Glycerin, Cetyl Alcohol (from Coconut Oil), Carbomer (Natural Thickener), Calendula Officitialis (Pot Marigold) Flower i Extract, Chamomilla Recutita (Chamomile) Flower Extract, Matrlcarla Cha-mornilla (Roman Chamomile) Flower Extract, Tilia Oficinalis (Linden) Ex-tract, Hypericum Perforatum (St. John's Wort) Extract, Centaurea Cyanus (Cornflower) Extract, Vitis Vinifera (Grape) Seed Extract, Tabebuia Impetiginosa (Pau d'Arco) Extract, Camellia Oleifera (Japanese Green Tea) Leaf Extract, Tocopheryl Acetate (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate (Natural Antimicrobial), Lonicera Japonica (Honeysuckle) Flower Extract, Lonicera Caprifolium (Honeysuckle) Extract, Populus Tremuloides (Aspen) Bark Extract, Gluconolactone (Natural Skin Conditioner)

Desert Harvest RELEVEUM

DESERT HARVEST RELEVEUM
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69145-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SAFFLOWER OIL (UNII: 65UEH262IS)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CHIA SEED OIL (UNII: MC2LH51BO7)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
ST. JOHN'S WORT (UNII: UFH8805FKA)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
TABEBUIA IMPETIGINOSA WHOLE (UNII: D65QWF3541)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69145-201-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2017
2	NDC:69145-201-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	07/30/2014

Labeler - Desert Harvest Inc. (034527161)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(69145-201)