Dimethicone 13%

Petrolatum 41.9%

Skin Protectant

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

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

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

Questions?

858-859-1188

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

Directions

Apply as needed

15g tube primary container image 15g carton artwork with drug facts box 28g tube primary artwork image 28g carton artwork with drug facts box 48g tube primary artwork image 48g tube carton artwork with drug facts box

CUROLOGY BARRIER BALM
skin barrier balm ointment

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
.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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	10/02/2023

Labeler - Curology (104103284)

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