Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Calamine 8%, Pramoxine HCl 1%
Navarro Discount Pharmacies, LLC
TOPICAL
OTC DRUG
Skin protectant Topical analgesic temporarily relieves pain and itching associated with: - rashes due to poison ivy, poison oac or poison sumac - insect bites - minor skin irritation - minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac
OTC monograph final
CALAMINE- ZINC OXIDE, FERRIC OXIDE RED, PRAMOZINE HCL LOTION NAVARRO DISCOUNT PHARMACIES, 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 Calamine 8% Pramoxine HCl 1% PURPOS E Skin protectant Topical analgesic US ES temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oac or poison sumac insect bites minor skin irritation minor cuts dries the oozing and weeping of poison ivy, poison oak and poison sumac WARNINGS FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT do not get into eyes STOP USE AND ASK A DOCTOR IF condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS shake well before use adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor OTHER INFORMATION store at 20° to 25°C (68° to 77°F) INACTIVE INGREDIENTS SD alcohol 38-B, camphor, diazolidinyl urea, fragrance, hypromellose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, zanthan gum PACKAGE LABEL CALAMINE zinc oxide, ferric oxide red, pramozine hcl lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:59 9 70 -0 75 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 0 mg in 1 mL FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75) (FERRIC OXIDE RED - UNII:1K0 9 F3G6 75) FERRIC OXIDE RED 8 0 mg in 1 mL PRAMO XINE HYDRO CHLO RIDE (UNII: 8 8 AYB8 6 7L5) (PRAMOXINE - UNII:0 6 8 X8 4E0 56 ) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME Perskaitykite visą dokumentą