Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)
United Exchange Corp.
TOPICAL
OTC DRUG
Uses Temporarily relieves pain and itching associated with: - insect bites - minor burns - sunburn - minor skin irritations - minor cuts - scrapes - rashes due to poison ivy - poison oak - poison sumac - drise the oozing and weeping of poison ivy, poison oak, and poison sumac Do not use - on large areas of the body - with any other product containing diphenhydramine, even one taken by mouth 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 Directions - do not use more than directed - 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
OTC monograph final
FAMILY CARE ANTI-ITCH- DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE CREAM UNITED EXCHANGE CORP. _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._ ---------- Active Ingredients Purpose Diphenhydramine hydrochloride 1%................................................ Topical analgesic Zinc acetate 0.1%........................................................................ Skin protectant Uses Temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy poison oak poison sumac drise the oozing and weeping of poison ivy, poison oak, and poison sumac Warnings For external use only Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles When using this product avoid contact with 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 immediately Directions do not use more than directed 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 between 20° to 25°C (68° to 77°F) Lot No. & Exp. Date: see box or see crimp of tube Inactive ingredients cetanol, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol Distributed by: United Exchange Corp. 17211 Valley View Ave. Cerritos CA 90703 USA Made in Korea FAMILY CARE ANTI-ITCH United Exchange Corp. diphenhydramine hydrochloride zinc acetate cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 59 23-49 5 ROUTE OF ADMINISTRATIO Прочитать полный документ