Otc - Active Ingredient
Active Ingredient Purpose
Zinc oxide, 40% ........................................................................Skin protectant
Western Family Diaper Rash
FDA Label NDC 68169-0375
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tai Guk Pharm. Co., Ltd. for the product Western Family Diaper Rash (NDC 68169-0375). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps protect skin from wetness
- helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips
Warnings
For external use only
Otc - Do Not Use
Do not use over deep or puncture wounds, infections or lacerations
Otc - When Using
When using this product avoid contact with the eyes
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve within 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Indications & Usage
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
Storage And Handling
Other information
- store at 20o to 25oC (68o to 77oF)
- Lot No. and Exp. Date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients
BHA, cod liver oil (high in vitamins A and D), fragrance, lanolin, light mineral oil, methylparaben, petrolatum, purified water, talc, tartrazine yellow #4 (FD and C yellow #4)
Dosage & Administration
Proudly Distributed By:
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208 U.S.A.
Copyright 2010 Marca Registrada
www.westernfamily.com
Package Label.Principal Display Panel
Image Of Carton Label (Wfdiaperrashointment)
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