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

Purpose

Skin Protectant

Description

White petrolatum 45%


Medication Information

Warnings

For external use only

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

Directions

apply as needed

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

Description

White petrolatum 45%

Principal Display Panel

ChapStick ®

SKIN PROTECTANT

TO:

FROM:

5 STICKS

NET WT 0.15 OZ

(4 g) EACH

203531 – Front Panel

Active Ingredient

White petrolatum 45%

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

Keep Out of Reach of Children

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


Structured Label Content

Warnings

For external use only

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

Directions

apply as needed

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ChapStick ®

SKIN PROTECTANT

TO:

FROM:

5 STICKS

NET WT 0.15 OZ

(4 g) EACH

203531 – Front Panel

Active Ingredient (Active ingredient)

White petrolatum 45%

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

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

All Sections (JSON)