Label: MANDELIC 2 PEEL GEL- allantoin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70663-003-01 - Packager: MESO SYSTEM S.A.
- 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 October 5, 2016
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- Official Label (Printer Friendly)
- Warnings
- WARNINGS
- USES
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- QUESTIONS OR COMMENTS ?
- ACTIVE INGREDIENTS
- Inactive Ingredients
- INDICATIONS & USAGE
- Mandelic_2 Peel Gel
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INGREDIENTS AND APPEARANCE
MANDELIC 2 PEEL GEL
allantoin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70663-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K) 2 mg in 1 mL WATER (UNII: 059QF0KO0R) 89.9 mg in 1 mL MANDELIC ACID (UNII: NH496X0UJX) 4.5 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 1 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg in 1 mL PROPANEDIOL (UNII: 5965N8W85T) 1 mg in 1 mL ALCOHOL (UNII: 3K9958V90M) 1.5 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70663-003-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/05/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/05/2016 Labeler - MESO SYSTEM S.A. (768263100) Registrant - MESO SYSTEM S.A. (768263100) Establishment Name Address ID/FEI Business Operations MESO SYSTEM S.A. 768263100 manufacture(70663-003)
