GOODSENSE DIAPER RASH- zinc oxide paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Geiss, Destin & Dunn, Inc.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness 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 Directions - change wet and soiled 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

Authorization status:

OTC monograph final

Summary of Product characteristics

GOODSENSE DIAPER RASH- ZINC OXIDE PASTE
GEISS, DESTIN & DUNN, 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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Active ingredient Purpose
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
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
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 at 20° to 25°C (68° to 77°F)
Lot No. & Exp. Date: see box or see crimp of tube
Inactive ingredients butylhydroxyanisole, lavender oil, liquid
paraffin, methylparaben, petrolatum,
polysorbate 60, purified lanolin, sorbitan monostearate, squalane,
talc, tocopherol, acetate, water
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
www.valuelabels.com
Made in Korea
GOODSENSE DIAPER RASH
zinc oxide paste
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 8 0 4-779
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
40 0 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)
LAVENDER O IL (UNII: ZBP1YXW0 H8 )
PARAFFIN (UNII: I9 O0 E3H2ZE)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PETRO LATUM (UNII: 4T6 H12BN9 U)
Geiss, Destin & Dunn, Inc.
PO LYS