Label: GLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENT liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 60541-1800-1 - Packager: Hayden Caleel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 28, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
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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
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Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- If bothersome dryness or peeling occurs, reduce use to once a day or every other ay
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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
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INGREDIENTS AND APPEARANCE
GLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENT
glo skin beauty clear skin spot treatment liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60541-1800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:60541-1800-1 1 in 1 CARTON 12/31/2017 1 15 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 final part333D 11/30/2017 Labeler - Hayden Caleel LLC (011367468) Registrant - Hayden Caleel LLC (011367468) Establishment Name Address ID/FEI Business Operations G.S. COSMECEUTICAL USA, INC. 017014734 manufacture(60541-1800)
