365 Everyday Value Medicated Lip Balm

365 Everyday Value Medicated Lip Balm
SPL v4
SPL
SPL Set ID 48309a7d-d2da-483c-8bf8-f59d9ad0bb73
Route
TOPICAL
Published
Effective Date 2019-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (0.0578 g)
Inactive Ingredients
Coconut Oil Yellow Wax Shea Butter Sunflower Oil Cocoa Butter Mentha Arvensis Leaf Oil Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-13

Description

DRUG FACTS


Medication Information

Warnings and Precautions

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.

Dosage and 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.

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of the reach of children.

Section 51727-6

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

Section 53413-1

Questions or comments?

[email protected]

■ 1-844-936-8255

Section 55105-1

Purpose

External Analgesic

Section 55106-9

Active ingredient:

Camphor 1.36%

Section 60561-8

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.

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


Structured Label Content

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments?

[email protected]

■ 1-844-936-8255

Section 55105-1 (55105-1)

Purpose

External Analgesic

Section 55106-9 (55106-9)

Active ingredient:

Camphor 1.36%

Section 60561-8 (60561-8)

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.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)