GLO SKIN BEAUTY REMEDY GEL- glo skin beauty remedy gel gel 
Hayden Caleel 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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DRUG FACTS

Active Ingredients

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only

Do not use

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

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

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

541-1900-3

GLO SKIN BEAUTY REMEDY GEL 
glo skin beauty remedy gel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60541-1900-31 in 1 CARTON12/31/2017
130 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/31/2017
Labeler - Hayden Caleel LLC (011367468)
Registrant - Hayden Caleel LLC (011367468)
Establishment
NameAddressID/FEIBusiness Operations
Island Kinetics, Inc. d.b.a. CoValence Laboratories959735002manufacture(60541-1900)

Revised: 12/2017
Document Id: 6168b2f3-1988-24bb-e053-2991aa0a8ca3
Set id: aa47ff08-07b3-4fd1-bae5-420e4b928f06
Version: 1
Effective Time: 20171228
 
Hayden Caleel LLC