365 Medicated Lip Balm
- Manufacturer
- Whole Foods Market, Inc. | Raining Rose, Inc
- Effective date
- 2023-11-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:46
Label at a glance#
Product365 Medicated Lip Balm
Active ingredientCAMPHOR (NATURAL)
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
OTC - ACTIVE INGREDIENT SECTION
Active ingredient:
Camphor 1.36%
OTC - PURPOSE SECTION
Purpose
External Analgesic
WARNINGS SECTION
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 SECTION
Keep out of the reach of children.
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
■ customer.questions@wholefoods.com
■ 1-844-936-8255
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42681-0001-1 | 2021-12-06 | C162847 | 48780-1 | ba0f9c33-130b-a910-e053-dadaa90a0b85 | 365 EVERYDAY VALUE Medicated Lip Balm |
| 42681-0001-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-130b-a910-e053-dadaa90a0b85 | 365 EVERYDAY VALUE Medicated Lip Balm |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42681-0001-1 | 365 Medicated Lip Balm | 4.25 g in 1 TUBE | STICK | 4.25 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42681-0001 | 365 MEDICATED LIP BALM (MEDICATED LIP BALM) STICK [WHOLE FOODS MARKET, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231104_48309a7d-d2da-483c-8bf8-f59d9ad0bb73.zip |
Products#
Every source-derived product name is available through these pages.
- 365 Medicated Lip Balm
- Medicated Lip Balm
- CAMPHOR (NATURAL)
- COCONUT OIL
- YELLOW WAX
- SHEA BUTTER
- SUNFLOWER OIL
- COCOA BUTTER
- MENTHA ARVENSIS LEAF OIL
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42681-0001 | 42681-0001-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAMPHOR (NATURAL) | N20HL7Q941 | ACTIB |
| COCONUT OIL | Q9L0O73W7L | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| SHEA BUTTER | K49155WL9Y | IACT |
| SUNFLOWER OIL | 3W1JG795YI | IACT |
| COCOA BUTTER | 512OYT1CRR | IACT |
| MENTHA ARVENSIS LEAF OIL | 1AEY1M553N | IACT |
| MENTHOL | L7T10EIP3A | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 365 Medicated Lip Balm | MEDICATED LIP BALM | Whole Foods Market, Inc. | 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 | 2023-11-03 | Warnings | 42681-0001-1 42681-0001 42681000101 9a822d2a-d9c2-4647-a74d-9641f949d96b 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.