Active Ingredient
Dimethicone 1.2%
P.o.v. Baby Moisturizing Fragrance Free
FDA Label NDC 63148-319
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apollo Health And Beauty Care Inc. for the product P.o.v. Baby Moisturizing Fragrance Free (NDC 63148-319). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
temporarily protects and helps relieve chapped or cracked skin, and helps protect from the drying effects of wind and cold.
Warnings
For external use only.
When Using This Product
avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop Use And Ask A Doctor If
condition worsens, or if irritation or redness develops and lasts more than 7 days, or clears up and recurs within a few days.
Keep Out Of Reach Of Children.
In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Directions
apply as needed.
Other Information
store at room temperature.
Inactive Ingredients
Water (Aqua), Glycerin, Petrolatum, Isopropyl Palmitate, Distearyldimonium Chloride, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Sodium Chloride, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.
Questions Or Comments?
1-866-695-3030
Label Copy
Image Of The Label (22863l)
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