Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
White Petrolatum USP (100%)
Salado Sales, Inc
TOPICAL
OTC DRUG
Skin Protectant helps protect chapped skin - deep or puncture wounds - animal bites - serious burns
OTC monograph final
PETROLEUM- WHITE PETROLATUM JELLY SALADO SALES, 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._ ---------- PETROLEUM JELLY 069.001/069AA ACTIVE INGREDIENTS White Petrolatum USP (100%) PURPOSE Skin Protectant USE helps protect chapped skin WARNINGS For external use only WHEN USING THIS PRODUCT do not get into eyes SEE A DOCTOR IF condition lasts more than 7 days DO NOT USE ON deep or puncture wounds animal bites serious burns KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS apply as needed INACTIVE INGREDIENT None ADVERSE REACTIONS Distributed by Salado Sales, Inc. 6201 NW H.K. Dodgen Loop Temple, TX 76504 saladosales.com PRINCIPAL DISPLAY PANEL CVP 100% PURE PETROLEUM JELLY WHITE PETROLATUM SKIN PROTECTANT NET WT 3.75 OZ (106 g) PETROLEUM white petrolatum jelly PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:57243-069 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 1 g in 1 g Salado Sales, Inc PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:57243-069- 54 106 g in 1 JAR; Type 0: Not a Combination Product 06/04/2003 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part347 06/04/2003 LABELER - Salado Sales, Inc (009830555) REGISTRANT - Vi-Jon, LLC (790752542) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Vi-Jon, LLC 088520668 manufacture(57243-069) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Vi-Jon, LLC 790752542 manufacture(57243-069) Revised: 1/2023 Les hele dokumentet