CHAPSTICK CLASSIC MEDICATED- external analgesic and skin protectant lip balm stick

ChapStick Classic Medicated by

Drug Labeling and Warnings

ChapStick Classic Medicated by is a Otc medication manufactured, distributed, or labeled by Suave Brands Co., LLC, Fareva Richmond Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Camphor

Menthol

White Petrolatum

INACTIVE INGREDIENT

Inactive Ingredients: arachidyl propionate, cetyl alcohol, Copernicia cerifera (carnauba) wax, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, Theobroma cacao (cocoa) seed butter, white wax

INDICATIONS & USAGE

Uses:

Helps prevent and temporarily protects chafed, chapped, or cracked lips

Temporary relief of pain associated with fever blisters and cold sores
Helps prevent and protect from the drying effects of wind and cold weather

KEEP OUT OF REACH OF CHILDREN

Warnings

• For external use only
• When using this product avoid contact with the eyes
• Stop use and ask a doctor if
  • Condition worsens
  • symptoms persist for more than 7 days or clear and ocur again within a few days
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Purpose

External analgesic

Skin Protectant

WARNINGS

Warnings

• For external use only
• When using this product avoid contact with the eyes
• Stop use and ask a doctor if
• Condition worsens
• symptoms persist for more than 7 days or clear and ocur again within a few days
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• adults and children under 2 years or age and older:

apply to lips not more than 3 to 4 times daily

• children under 2 years of age: ask doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHAPSTICK CLASSIC MEDICATED 
external analgesic and skin protectant lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83711-809
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.6 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COPERNICIA CERIFERA (CARNAUBA) WAX (UNII: R12CBM0EIZ)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
ISOPROPYL LAURATE (UNII: U0JQ94LABM)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)	41 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H)
CETYL ALCOHOL (UNII: 936JST6JCN)
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
PARAFFIN (UNII: I9O0E3H2ZE)
WHITE WAX (UNII: 7G1J5DA97F)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
FRAGRANCE 13576 (UNII: 5EM498GW35)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83711-809-50	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	10/31/2025
2	NDC: 83711-809-51	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	10/31/2025
3	NDC: 83711-809-47	4 g in 1 APPLICATOR; Type 0: Not a Combination Product	10/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/31/2025

Labeler - Suave Brands Co., LLC (118965468)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Richmond Inc		969523245	manufacture(83711-809) , pack(83711-809)