DIAPER RASH- zinc oxide paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zinc oxide 40%

Available from:

Harmon Stores, Inc

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 - 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

DIAPER RASH- ZINC OXIDE PASTE
HARMON STORES, 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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FACE VALUES 020.002 020AD
ACTIVE INGREDIENTS
Zinc oxide 40%
PURPOS E
Skin protectant
US E
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 soilded diapers promptly
cleanse the diaper area
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 and 25 C (68 and 77 F)
INACTIVE INGREDIENTS
petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin,
sorbitan sesquioleate, beeswax,
tocopheryl acetate, fragrance
ADVERSE REACTIONS
Dist. by Harmon Stores, Inc.
650 Liberty Ave.
Union, MJ 07083 USA
Visit us at: www.facevalues.com
Made in the USA with U.S. and imported parts
020.002/020AC
PRINCIPAL DISPLAY PANEL
HARMON
FACEVALUES
Diaper Rash
PASTE
PEDIATRICAN TESTED
HELPS SOOTHE, HEAL & PREVENT DIAPER RASH
40% ZINC OXIDE DIAPER RASH PASTE
Skin Protectant
NET WT 4 OZ (113 g)
DIAPER RASH
zinc oxide paste
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 39 40 -0 20
ROUTE OF ADMINISTRATION
TOPICAL
Harmon Stores, Inc
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
532 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PETRO LATUM (UNII: 4T6 H12BN9 U)
CO D LIVER O IL (UNII: BBL28 1NWFG)
LANO LIN (UNII: