Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 84d8cc38-83e3-49be-b180-d01820525b60
Route
TOPICAL
Published
Effective Date 2022-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (450 mg)
Inactive Ingredients
Arachidyl Propionate Camphor (natural) Carnauba Wax Cetyl Alcohol Isopropyl Myristate Lanolin Light Mineral Oil Menthol, Unspecified Form Octyldodecanol Paraffin Phenyl Trimethicone D&c Red No. 6 Saccharin White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

Description

Active ingredient White Petrolatum 45%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Dosage and Administration

Directions

apply as needed

Description

Active ingredient White Petrolatum 45%

Section 44425-7

Other Information

store at 20-25°C (68-77°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Section 53413-1

Questions or Comments?

Call weekdays from 9 AM to 6 PM EST at 1-800-245-1040

Section 55105-1

Purpose

Skin Protectant

Section 55106-9

Active ingredient

White Petrolatum 45%

Additional Information

Paraben Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.chapstick.com

Trademarks owned or licensed by GSK.

©2021 GSK or licensor

Principal Display Panel

BRAND LIP CARE

ChapStick ®

SKIN PROTECTANT

Supreme

CLASSIC CHERRY

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000071831


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Dosage and Administration (34068-7)

Directions

apply as needed

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other Information

store at 20-25°C (68-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Section 53413-1 (53413-1)

Questions or Comments?

Call weekdays from 9 AM to 6 PM EST at 1-800-245-1040

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Section 55106-9 (55106-9)

Active ingredient

White Petrolatum 45%

Additional Information (Additional information)

Paraben Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.chapstick.com

Trademarks owned or licensed by GSK.

©2021 GSK or licensor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BRAND LIP CARE

ChapStick ®

SKIN PROTECTANT

Supreme

CLASSIC CHERRY

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000071831


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)