País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Zinc Oxide 4%
Fortunique B.V.
TOPICAL
OTC DRUG
Skin protectant Helps treat and prevent diaper rash Helps seal out wetness Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days Not to be applied over deep or puncture wound, infection or lacerations
OTC monograph final
BUTTIEZZZ DAILY- ZINC OXIDE SPRAY FORTUNIQUE B.V. _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 ACTIVE INGREDIENTS Zinc Oxide 4% PURPOS E Skin protectant US ES Helps treat and prevent diaper rash Helps seal out wetness WARNING For external use only When using this product Avoid contact with eyes STOP USE AND CONTACT A DOCTOR IF: Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days Not to be applied over deep or puncture wound, infection or lacerations KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away DIRECTIONS Change wet or soiled diapers promptly Shake well before use Make sure the skin is clean and dry before use.Use a sweeping movement to spray-on the cream in a thin and uniform layer on the buttocks Allow to dry Use a spraying distance approximately 2 to 3 inches Apply Buttiezzz Daily liberally as often as necessary or at every diaper change OTHER INFORMATION Store at room temperature below 77º F INACTIVE INGREDIENTS Water(Aqua) Coco-Caprylate/Caprate Glycerin Alkyl- Alcohols Alkyl Glucoside Propylene glycol Cocoglycerides Caprylyl Glycol Capryl-Hidroxamic acid Chamomilla Recutita(Matricaria)Flower Extract Calendula Officinalis Flower Extract Silica Oleic Acid PRINCIPLE DISPLAY PANEL.50ML BOTTLE SPRAY CARTON BUTTIEZZZ DAILY zinc oxide spray PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:70 359 -410 1 ROUTE OF ADMINISTRATION TOPICAL Fortunique B.V. ROUTE OF ADMINISTRATION ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CAPRYLHYDRO XAMIC ACID (UNII: UPY8 0 5K9 9 W) C12 -2 0 ALKYL GLUCO SIDE (UNII: K6 7N5Z1RUA) C14 -2 2 ALCO HO LS (UNII: B1K8 9 Llegiu el document complet