Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
Allantoin 0.5%, Menthol 0.15%
Aidance Skincare & Topical Solutions, LLC
OTC DRUG
Allantoin - Skin Protectant Menthol - Topical Anesthetic For temporary protection and relief of pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites.
OTC monograph final
TERRASIL ITCH, RASH AND PAIN RELIEF- ALLANTOIN, MENTHOL OINTMENT AIDANCE SKINCARE & TOPICAL SOLUTIONS, 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._ ---------- DRUG FACTS ACTIVE INGREDIENTS Allantoin 0.5%, Menthol 0.15% PURPOS E Allantoin - Skin Protectant Menthol - Topical Anesthetic US ES For temporary protection and relief of pain and itching associated with minor skin irritations, rashes, eczema and/or insect bites. WARNINGS FOR EXTERNAL USE ONLY. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinue use and consult physician. If swallowed, consult physician. Do not bandage tightly. IF PREGNANT OR BREAST FEEDING, contact physician prior to use. KEEP OUT OF REACH OF CHILDREN. If swallowed, consult physician. DIRECTIONS Apply directly to effected area. Do not use more than four times per day. Store at room temperature. INACTIVE INGREDIENTS bentonite, cera alba (organic beeswax), cotton seed oil, eucalyptus citriodora oil, magnesium oxide, peppermint oil, silver oxide, simmondsia chinensis (jojoba) seed oil, zinc oxide. PRINCIPAL DISPLAY PANEL - 44G LABEL Aidance Skincare & Topical Solutions, LLC TERRASIL ITCH, RASH AND PAIN RELIEF allantoin, menthol ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:249 0 9 -154 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALLA NTO IN (UNII: 344S277G0 Z) (Allanto in - UNII:344S277G0 Z) Alla nto in 0 .5 g in 10 0 g MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL 0 .15 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH BENTO NITE (UNII: A3N5ZCN45C) CO TTO NSEED O IL (UNII: H3E8 78 0 20 N) EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2) JO JO BA O IL (UNII: 724GKU717M) MAGNESIUM O XIDE (UNII: 3A3U0 GI71G) PEPPERMINT O IL (UNII: AV0 9 Διαβάστε το πλήρες έγγραφο