देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Blistex Inc
TOPICAL
OTC DRUG
SKIN PROTECTANT/ SUNSCREEN
OTC monograph final
BLISTEX FIVE STAR- LIP PROTECTION STICK BLISTEX 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._ ---------- DRUG FACTS Petrolatum Hemosalate Octinoxate Oxybenzone Octisalate SKIN PROTECTANT/ SUNSCREEN Temporarily protects and helps relieve chapped or cracked lips Helps protect lips from the drying effects of wind, cold weather Helps prevent sunburn FOR EXTERNAL USE ONLY Do not use on * deep puncture wounds* animal bites* serious burns Stop use if skin rash occurs Adults and children 2 years of age and older: apply liberally to affected area not more than 3 to 4 times daily. Children under 2 years of age : consult a doctor. BLISTEX FIVE STAR LIP PROTECTION Holds in moisture in DRY air Soothes COLD chapped lips Rehydrates HEAT stressed lips Forms a WIND resistant moisture shield UVA/UVB SUN protection NET WT. .15oz. (4.25g) SPF Blistex Inc BLISTEX FIVE STAR lip protection stick PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:10 157-9 8 25 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PETRO LATUM (UNII: 4T6 H12BN9 U) (PETROLATUM - UNII:4T6 H12BN9 U) PETROLATUM 30 .1 g HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 9 .6 g O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W) OCTISALATE 5.0 g O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y) OXYBENZONE 5.0 g PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:10 157-9 8 25-1 1 in 1 BOX 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 rt347 0 5/0 1/20 10 LABELER - Blistex Inc (005126354) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RA पूरा दस्तावेज़ पढ़ें