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Chapice original spf 4 lip balm - Prescription Drug Labeling

Product NDC Code 63645-130
Drug Name

Chapice original spf 4 lip balm

Type Brand
Active Ingredients
Petrolatum 44 mg/g
Padimate o 1.5 mg/g
Route TOPICAL
Dosage Form STICK
Application Number part352
Labeler Name OraLabs
Packages
Package NDC Code Description
63645-130-02 1 g in 1 container (63645-130-02)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Padimate O, Petrolatum

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Mineral Oil, Ozokerite, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen, Skin Protectant

Spl product data elements

Usually a list of ingredients in a drug product.
ChapIce Original SPF 4 Lip Balm Padimate O, Petrolatum PETROLATUM PETROLATUM MICROCRYSTALLINE WAX LANOLIN PADIMATE O PADIMATE O CERESIN CARNAUBA WAX ISOPROPYL MYRISTATE LIGHT MINERAL OIL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package/Label Principal Display Panel ChapIce Original SPF 4 Lip Balm

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep Out of Reach of Children If swallowed get medical help or contact a Poison Control Center right away.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging. For external use only Stop use and ask a doctor: If rash or irritation develops and lasts.

Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API