FDA Label for Premier Value Zinc Oxide
View Indications, Usage & Precautions
Premier Value Zinc Oxide Product Label
The following document was submitted to the FDA by the labeler of this product Tai Guk Pharm. Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient Purpose
Zinc oxide, 20% ..............................................................................Skin protectant
Otc - Purpose
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
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
- Lot No. and Exp. Date: see box or see crimp of tube
- store at 20o to 25oC (68o to 77oF)
Inactive Ingredient
Inactive ingredients
White petrolatum, talc, purified lanolin, liquid paraffin, triethanolamine, aloe vera gel, tocopherol acetate, butylated hydroxyloluene, methyl parahydroxybenzoate, purified water
Dosage & Administration
Distributed By:
Chain Drug Consortium, LLC.
3301 N.W. Boca Raton Blvd., Suite 101
Boca Raton, FL 33431
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