Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 6df216dc-c03d-463a-8029-5e54c1dc3d27
Route
TOPICAL
Published
Effective Date 2023-06-09
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 Octyldodecanol Oleyl Alcohol Paraffin Phenyl Trimethicone D&c Red No. 6 Titanium Dioxide White Wax Fd&c Yellow No. 5 Lemon Oil, Cold Pressed Maltol Saccharin Levomenthol Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: pink Color: red Color: green Size: 42 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

White petrolatum 45%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

White petrolatum 45%

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

For external use only

Directions

apply as needed

Active Ingredient

White petrolatum 45%

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

arachidyl propionate, *blue 1 lake, *camphor, carnauba wax, cetyl alcohol, *fragrance, isopropyl lanolate, isopropyl myristate, lanolin, *lemon oil, light mineral oil, *maltol, *menthol, *natural and artificial flavor, octyldodecanol, *oleyl alcohol, paraffin, phenyl trimethicone, *red 6 lake, *saccharin, *titanium dioxide, white wax, *yellow 5 lake

*contains one or more of these ingredients

Additional Information

Paraben Free

Dist. by: GSK CH, Warren, NJ 07059

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

Questions or Comments? 1-800-245-1040

Trademarks owned or licensed by GSK.

©2023 GSK or licensor.

203531

Questions Or Comments?

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

Principal Display Panel

ChapStick ®

SKIN PROTECTANT

TO:

FROM:

5 STICKS

NET WT 0.15 OZ

(4 g) EACH

203531 – Front Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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

Skin Protectant

Warnings

For external use only

Directions

apply as needed

Active Ingredient (Active ingredient)

White petrolatum 45%

Other Information (Other information)

store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

arachidyl propionate, *blue 1 lake, *camphor, carnauba wax, cetyl alcohol, *fragrance, isopropyl lanolate, isopropyl myristate, lanolin, *lemon oil, light mineral oil, *maltol, *menthol, *natural and artificial flavor, octyldodecanol, *oleyl alcohol, paraffin, phenyl trimethicone, *red 6 lake, *saccharin, *titanium dioxide, white wax, *yellow 5 lake

*contains one or more of these ingredients

Additional Information

Paraben Free

Dist. by: GSK CH, Warren, NJ 07059

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

Questions or Comments? 1-800-245-1040

Trademarks owned or licensed by GSK.

©2023 GSK or licensor.

203531

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ChapStick ®

SKIN PROTECTANT

TO:

FROM:

5 STICKS

NET WT 0.15 OZ

(4 g) EACH

203531 – Front Panel

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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