Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)
Trifecta Pharmaceuticals USA LLC
TOPICAL
OTC DRUG
Skin Protectant Temporarily protects and relieves - minor cuts - scrapes - burns - chapped or cracked skin and lips Condition worsens Symptoms last more than 7 days or clear up and occur again with a few days - On deep or puncture wounds - Animal Bites - Serious Burns
OTC monograph final
WHITE PETROLATUM- PETROLATUM OINTMENT TRIFECTA PHARMACEUTICALS USA LLC _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._ ---------- GLOBE WHITE PETROLATUM OINTMENT ACTIVE INGREDIENT White Petrolatum 100% PURPOSE Skin Protectant USES Temporarily protects and relieves minor cuts scrapes burns chapped or cracked skin and lips STOP USE AND ASK A DOCTOR Condition worsens Symptoms last more than 7 days or clear up and occur again with a few days KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately WHEN USING THIS PRODUCT Avoid contact with eyes DO NOT USE On deep or puncture wounds Animal Bites Serious Burns DIRECTIONS Apply as needed INACTIVE INGREDIENTS mineral oil, vitamin A Palmitate, vitamin D3, Microcrystalline Wax, Paraffin DISTRIBUTED BY TRIFECTA PHARMACEUTICALS USA 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301 WWW.TRIFECTA-PHARMA.COM 1-888-296-9067 WARNINGS FOR EXTERNAL USE ONLY QUESTIONS Call: 1-888-296-9067 Store at room temperature 20º-25ºC (68º-77ºF) Tamper evident, do not use if packet is torn, cut or opened Avoid excessive heat and humidity PACKAGE LABEL WHITE PETROLATUM petrolatum ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:69396-114 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 100 g in 100 g PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:69396-114- 05 144 in 1 CARTON 10/14/2022 1 5 g in 1 PACKET; Type 0: Not a Combination Product Trifecta Pharmaceuticals USA LLC MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC monograph final part347 10/14/2022 LABELER - Trifecta Pharmaceuticals USA LLC (07942 Izlasiet visu dokumentu