CUROLOGY BARRIER BALM- skin barrier balm ointment

Curology Barrier Balm by

Drug Labeling and Warnings

Curology Barrier Balm by is a Otc medication manufactured, distributed, or labeled by Curology, Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dimethicone 13%

Petrolatum 41.9%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Uses

• Helps prevent, temporarily protects and helps relieve chafed, chapped or cracked skin
• Helps prevent and protect from the drying effects of wind and cold weather
• Temporarily protects minor
  1. cuts
  2. scrapes
  3. burns

For External Use Only

Apply as needed

WARNINGS

For external use only

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

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes

Stop use and ask doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

INACTIVE INGREDIENT

Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Aluminum Starch Octenylsuccinate, Synthetic Wax, Polyhydroxystearic Acid, Water, Zinc Oxide, Tocopheryl Acetate, Sodium Hyaluronate, Triethoxycaprylylsilane, BHT.

QUESTIONS

Questions?

858-859-1188

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

Apply as needed

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CUROLOGY BARRIER BALM 
skin barrier balm ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82575-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE 20 (UNII: H8YMB5QY0D) (DIMETHICONE 20 - UNII:H8YMB5QY0D)	DIMETHICONE 20	13 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	41.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SHEA BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
ZINC OXIDE (UNII: SOI2LOH54Z)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Product Characteristics
Color	white (Paste)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82575-302-02	1 in 1 CARTON	10/02/2023
1	NDC: 82575-302-01	15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82575-302-04	1 in 1 CARTON	10/02/2023
2	NDC: 82575-302-03	28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 82575-302-06	1 in 1 CARTON	10/02/2023
3	NDC: 82575-302-05	48 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	10/02/2023

Labeler - Curology (104103284)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(82575-302)