PREMIER VALUE ZINC OXIDE- zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chain Drug Consortium, LLC

INN (International Name):

ZINC OXIDE

Composition:

ZINC OXIDE 20 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps protect skin from wetness - protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac - helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips 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

Authorization status:

OTC monograph final

Summary of Product characteristics

PREMIER VALUE ZINC OXIDE - ZINC OXIDE CREAM
CHAIN DRUG CONSORTIUM, 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 ingredient Purpose
Zinc Oxide
20%.............................................................Skin
protectant
Uses
helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps protect skin from
wetness
protects and dries the oozing and weeping of poison ivy, poison oak
and poison sumac
helps prevent and temporarily protect chafed, chapped, cracked or
windburned skin and lips
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
Lot No. and Exp. Date: see box or see crimp of tube
store at 20° to 25°C (68° to 77°F)
Inactive ingredients aloe vera gel, liquid paraffin, tocopherol
acetate, white beeswax, white petrolatum
Distributed By
Chain Drug Consortium
3301 NW Boca Raton Blvd. Suite 101
Boca Raton, FL 33431
Made in Korea
PREMIER VALUE ZINC OXIDE
zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 0 16 -252
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
20 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
MINERAL O IL (UNII: