QUALITY CHOICE MAXIMUM STRENGTH ZINC OXIDE- zinc oxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Chain Drug Marketing Association Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days

Authorization status:

OTC monograph final

Summary of Product characteristics

QUALITY CHOICE MAXIMUM STRENGTH ZINC OXIDE- ZINC OXIDE OINTMENT
CHAIN DRUG MARKETING ASSOCIATION INC
_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._
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QC ZINC OXIDE OINTMENT 2 OZ 99197 ZDP
ACTIVE INGREDIENT
Zinc oxide 40%...........................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
IF PREGNANT OR BREAST-FEEDING
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)
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 exposure to wet diapers may be prolonged
OTHER INFORMATION
store at 20°-25°C (68°-77°F)
may stain clothing
INACTIVE INGREDIENTS
.alpha.-tocopherol acetate, butylated hydroxytoluene, lanolin,
lavender oil, light mineral
oil, methylparaben, petrolatum, polysorbate 60
DISTRIBUTED BY:
C.D.M.A., INC.
43157 W. NINE MILE
NOVI, MI 48376
www.qualitychoice.com
Made in China
Chain Drug Marketing Association Inc
QUALITY CHOICE MAXIMUM STRENGTH ZINC OXIDE
zinc oxide ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:63868-500
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ZINC CATION
40 g in 100 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PO