Country: United States
Language: English
Source: NLM (National Library of Medicine)
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)
MEGASOL COSMETIC GMBH
GLYCERIN
GLYCERIN 5 g in 100 mL
OTC DRUG
OTC monograph not final
EROS FISTING GEL SLIDE X- GLYCERIN GEL MEGASOL COSMETIC GMBH _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 GLYCERIN 5% PURPOSE SKIN PROTECTANT USES HELPS LUBRICATING IN BODY MASSAGE WARNING: FOR EXTERNAL USE ONLY STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS. KEEP OUT OF REACH OF CHILDREN INACTIVE INGREDIENTS: WATER, PROPYLENE GLYCOL, CYCLOMETHICONE, SODIUM ACRYLATE/ACRYLOYLDIMETHYL TAURATE, DIMETHICONOL, ISOHEXADECANE, POLYSORBATE 80, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN DIRECTIONS FOR USE: APPLY AS NEEDED OPEN THE CAP, SQUEEZE TUBE TO OBTAIN DESIRED AMOUNT OF LUBRICANT. MAY BE APPLIED DIRECTLY ONTO CONDOMS. REAPPLY AS NEEDED. CLOSE CP AFTER USE. RINSE WITH WATER TO REMOVE. EROS FISTING GEL SLIDE X glycerin gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:5338 9 -512 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX) GLYCERIN 5 g in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) CYCLO METHICO NE (UNII: NMQ3479 9 4Z) SO DIUM ACRYLATE/SO DIUM ACRYLO YLDIMETHYLTAURATE CO PO LYMER ( 4 0 0 0 0 0 0 MW) (UNII: 1DXE3F3OZX) DIMETHICO NO L ( 2 0 0 0 CST) (UNII: T74O12AN6 Y) ISO HEXADECANE (UNII: 9 18 X1OUF1E) PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H) HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP) MEGASOL COSMETIC GMBH PHENO XYETHANO L (UNII: HIE49 2ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:5338 9 -512-17 20 0 mL in 1 TUBE MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no Read the complete document