国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Zinc Oxide (2.5mgs per 1g of product by input weight)
Envisionate PSJ LLC
TOPICAL
OTC DRUG
External analgesic For temporary relief of pain and itching associated with fever blisters and cold sores
OTC monograph not final
COLDSORE BOMB- ZINC OXIDE OINTMENT ENVISIONATE PSJ 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._ ---------- COLDSORE BOMB DRUG FACTS ACTIVE INGREDIENTS Zinc Oxide (2.5mgs per 1g of product by input weight) PURPOS E External analgesic US E For temporary relief of pain and itching associated with fever blisters and cold sores WARNINGS FOR EXTERNAL USE ONLY STOP USE AND ASK A DOCTOR IF Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days WHEN USING THIS PRODUCT Avoid contact with the eyes KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222). DIRECTIONS Adults and children 2 years of age and older: Apply to the affected area not more than 3-4 times daily Children under 2 years of age: Consult a doctor OTHER INFORMATION Store at room temperature 68 to 77°F (20 to 25ºC). INACTIVE INGREDIENTS Lanolin, Cocoa Butter, Coconut Oil, Grapeseed Oil, Peppermint Oil, Tea Tree Oil, Croton Lechleri Sap (Dragons Blood) QUESTIONS OR COMMENTS? (801) 623-1595 M-F 9am-5pm or visit our website at COLDSOREBOMB.COM "EXPLOSIVE COLD SORE RELIEF" 100% ALL NATURAL DISTRIBUTED BY: Envisionate PSJ Lehi UT 84043 NDC 72883-019-01 PACKAGING Envisionate PSJ LLC COLDSORE BOMB zinc oxide ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:728 8 3-0 19 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37) ZINC CATION 2.5 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH LANO LIN (UNII: 7EV6 5EAW6 H) CO CO A BUTTER (UNII: 512OYT1CRR) CO CO NUT O IL (UNII: Q9 L0 O73W7L) GRAPE SEED O IL (UNII: 9 30 MLC8 XGG) PEPPERMINT O IL (UNII: AV0 9 2KU4JH) TEA TREE O IL (UNII: VIF56 5UC2G) CRO TO N LECHLERI RESIN (UNII: 阅读完整的文件