GLO SKIN BEAUTY REMEDY GEL gel

glo SKIN BEAUTY Remedy Gel by

Drug Labeling and Warnings

glo SKIN BEAUTY Remedy Gel by is a Otc medication manufactured, distributed, or labeled by Hayden Caleel LLC, Island Kinetics, Inc. d.b.a. CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• temporarily relieves itching associate with minor skin irritations, inflammation an rashes due to:
• dermatitis, exzema, insect bites
• other uses of this prouct should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• for the treatment of iaper rash. Ask a doctor

When using this product
avoid contact with the eyes
do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hyrdrocortisone product unless you have asked a doctor

Keep out of reach of children

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

Directions

• for itching of skin irritation, inflamation and rashes
• adults an chilren 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, ask a doctor

Inactive Ingredients

Aqua (Water), Glycerin, Caprylic/Capric Triglyceride, Cetearyl Olivate, Rosa Canina (Rose Hip) Fruit Oil, Squalane, Sorbitan Olivate, Bisabolol, Carbomer, Gluconolactone, Lonicera Caprifolium (Honeysuckle) Flower Extract, Hedychium Coronarium (White Ginger) Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Sodium Benzoate, Phenethyl Alcohol, Potassium Sorbate, Caprylyl Glycol, Tocopherol, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice Powder, Phytic Acid, Sodium Hydroxide, Xanthan Gum, Trisodium Ethylenediamine Disuccinate

Principal Display Panel

INGREDIENTS AND APPEARANCE

GLO SKIN BEAUTY REMEDY GEL 
glo skin beauty remedy gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60541-1900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SQUALANE (UNII: GW89575KF9)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
SODIUM HYDRIDE (UNII: 23J3BHR95O)
XANTHAN GUM (UNII: TTV12P4NEE)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60541-1900-3	1 in 1 CARTON	12/31/2017
1		30 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/31/2017

Labeler - Hayden Caleel LLC (011367468)

Registrant - Hayden Caleel LLC (011367468)

Establishment
Name	Address	ID/FEI	Business Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories		959735002	manufacture(60541-1900)