LEADER DIAPER RASH CREAM- diaper rash cream cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Cardinal Health

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

LEADER DIAPER RASH CREAM- DIAPER RASH CREAM CREAM
CARDINAL HEALTH
_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._
----------
CR-1189
_ACTIVE INGREDIENT_
Zinc Oxide 40%
_PURPOSE_
Skin Protectant
_USES_
helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps seal out wetness
_WARNINGS_
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not get into eyes
STOP USE AND ASK A DOCTOR IF
condition worsens
symptoms last 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_
change wet and soiled diapers promptly
cleanse the diaper area, and allow to dry
apply paste 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 between 20° to 25°C (68° to 77°F)
may stain clothing
_INACTIVE INGREDIENTS_
white soft paraffine, COD liver oil, lanoline, talcum, glycerine,
sorbitan soquioleate, beeswax,
tocopheryl acetate, fragrance.
_QUESTIONS?_
_QUESTIONS?_
_1-888-DYNAREX_
_LABEL_
LEADER DIAPER RASH CREAM
diaper rash cream cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:3720 5-9 8 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
Cardinal Health
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
4 g in 10 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CO D LIVER O IL (UNII: BBL28 1NWFG)
LANO LIN (UNII: 7EV6 5EAW6 H)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6 A3C0 OX)
SO RBITAN SESQ UIO LEATE (UNII: 0 W8 RRI5W5A)
YELLO W WAX (UNII: 2ZA36 H0 S2V)
LIQ UID PETRO LEUM (UNII: 6 ZAE7X6 8 8 J)
ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START