365 Medicated Lip Balm Stick
FDA Label NDC 42681-0001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Whole Foods Market, Inc. for the product 365 Medicated Lip Balm (NDC 42681-0001). 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 other, otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Otc - Active Ingredient

Active ingredient:
Camphor 1.36%

Otc - Purpose

Purpose
External Analgesic

Warnings

Warnings
For external use only. When using this product avoid contact with 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 the reach of children.
Do not use on: deep puncture wounds, serious burns, animal bites. If swallowed,
get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Dosage & Administration

Directions■ Adults and children 2 years of age and older: Apply to lips not
more than 3 to 4 times daily ■ Children under 2 years of age: consult a doctor.

Other Safety Information

Other information
This is a personal care item and should only be used by one individual only. Protect this
product from excessive heat and direct sun.

Inactive Ingredient

Inactive ingredients cocos nucifera (coconut) oil*, beeswax*,
butyrospermum parkii (shea) butter*, helianthus annuus (sunflower) seed oil*, theobroma
cacao (cocoa) seed butter*, mentha arvensis leaf oil*, menthol*. *organic ingredient

Principal Display Package

NDC 42681-0001-1

365
EVERYDAY VALUE

medicated
LIP BALM

Soothing Relief For Dry,
Chapped Lips

NET WT 0.15 OZ (4.25g)                FPO

0 99482 48844 4

DISTRIBUTED BY: WHOLE FOODS MARKET | 550 BOWIE STREET AUSTIN, TX 78703
©2019 WHOLE FOODS MARKET IP, LP
MADE IN USA FROM DOMESTIC AND IMPORTED INGREDIENTS

SAFETY
SEAL

rege

* Please review the disclaimer below.