מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
AMERICAN SALES
TOPICAL
OTC DRUG
Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps protect skin from wetness Do not use over deep or puncture wounds, infections or lacerations Stop use and ask a doctor if condition worsens or does not improve within 7 days Directions - change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry - apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
OTC monograph final
COTTONTAILS DIAPER RASH - ZINC OXIDE OINTMENT AMERICAN SALES _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 Ingredient Purpose Zinc oxide, 40% .....................................................................Skin protectant Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect skin from wetness Warnings For external use only Do not use over deep or puncture wounds, infections or lacerations When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged Other information store at 20 to 25 C (68 to 77 F) Lot No. and Exp. Date: see box or see crimp of tube Inactive ingredients BHA, cod liver oil (high in vitamin A and D), fragrance, lanolin, methylparaben, petrolatum, talc and purified water, light mineral oil, tartrazine yellow #4 (FD and C yellow #4) DISTRIBUTED BY: AMERICAN SALES COMPANY 4201 WALDEN AVENUE, LANCASTER, NY 14086 www.Care1.info Made in Korea o o o o Enter section text here COTTONTAILS DIAPER RASH zinc oxide ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:41520 -343 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 0 .4 g in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K) CO D LIVER O IL (UNII: BBL28 1NWFG) MINERAL O IL (UNII: T5L8 T28 קרא את המסמך השלם