365 MEDICATED LIP BALM- medicated lip balm stick

365 Medicated Lip Balm by

Drug Labeling and Warnings

365 Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by Whole Foods Market, Inc., Raining Rose, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active ingredient:
Camphor 1.36%

PURPOSE

Purpose
External Analgesic

INDICATIONS & USAGE

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.

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

QUESTIONS

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

INGREDIENTS AND APPEARANCE

365 MEDICATED LIP BALM 
medicated lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.0578 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0001-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	06/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/13/2019

Labeler - Whole Foods Market, Inc. (196175616)

Registrant - Raining Rose, Inc (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc		083819404	manufacture(42681-0001)