GLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENT- glo skin beauty clear skin spot treatment liquid 
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

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Uses

Warnings

Using other topical acne medications at the same tiem or immediatly following use of this prouct may increase dryness or irritation of the skin. If this occurs, only one medication shoul be used unless directed by a doctor.

For external use only
When using this product
• avoid contact with the eyes
• if contact occurs, rinse thoroughly with water
• do not use on damaged or broken skin

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

Water, Glycerin, Propylene Glycol, Sorbitol, Cucumis Sativa (Cucumber) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Triethanolamine, Carbomer, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin

Principal Display Panel

60541-1800-1.jpg

GLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENT 
glo skin beauty clear skin spot treatment liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60541-1800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
TRIETHANOLAMINE DIOLEATE (UNII: 40Q022F4GX)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60541-1800-11 in 1 CARTON12/31/2017
115 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/30/2017
Labeler - Hayden Caleel LLC (011367468)
Registrant - Hayden Caleel LLC (011367468)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734manufacture(60541-1800)

Revised: 12/2017
Document Id: 61676c71-b1eb-266c-e053-2991aa0aa1a3
Set id: 9f33ffc7-2727-491e-a361-7f130c81d1b1
Version: 1
Effective Time: 20171228
 
Hayden Caleel LLC