Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Caribe Natural, Inc
TOPICAL
OTC DRUG
Sulfur 10% ointment Sulfur 10% Ointment
OTC monograph final
SULFUR- SULFUR OINTMENT CARIBE NATURAL, INC _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._ ---------- ACTIVE INGREDIENT PURPOSE Sulfur 10% ...................... ointment Sulfur 10% ointment Keep out of reach of children. Sulfur 10% Ointment Sulfur 10% Ointment Sulfur 10% Ointment cetyl/stearyl alcohol, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, polyethylenglycol, propylparaben, sorbitan oleate, water SULFUR sulfur ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:59 56 1-70 6 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 ) SULFUR 10 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S) GLYCERIN (UNII: PDC6 A3C0 OX) GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4) METHYLPARABEN (UNII: A2I8 C7HI9 T) MINERAL O IL (UNII: T5L8 T28 FGP) PARAFFIN (UNII: I9 O0 E3H2ZE) Caribe Natural, Inc PO LYETHYLENE GLYCO L 10 0 0 (UNII: U0 76 Q6 Q6 21) PETRO LATUM (UNII: 4T6 H12BN9 U) PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) PRO PYLPARABEN (UNII: Z8 IX2SC1OH) SO RBITAN MO NO O LEATE (UNII: 0 6 XEA2VD56 ) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:59 56 1-70 6 -0 2 57 g in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt333D 0 5/0 5/20 15 LABELER - Caribe Natural, Inc (624210480) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Wo rld Perfumes, Inc 10 13120 44 ma nufa c ture (59 56 1-70 6 ) Revised: 5/2015 Leggi il documento completo