Barrier Balm by Autumn Harp, Inc. / Autumn Harp BARRIER BALM ointment

Barrier Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Petrolatum 41.9%

Dimethicone 13.0%

PURPOSE

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 cuts, scrapes, burns

INDICATIONS & USAGE

Directions

Apply as needed

WARNINGS

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, Sodium Hyaluronate, Water, Zinc Oxide, Tocopheryl Acetate, Triethoxycaprylylsilane

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

Apply as needed

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BARRIER BALM 
barrier balm ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0363
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
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ZINC OXIDE (UNII: SOI2LOH54Z)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
WATER (UNII: 059QF0KO0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0363-2	1 in 1 CARTON	10/02/2023
1	NDC: 51514-0363-1	15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51514-0363-4	1 in 1 CARTON	10/02/2023
2	NDC: 51514-0363-3	28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 51514-0363-6	1 in 1 CARTON	10/02/2023
3	NDC: 51514-0363-5	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 Drug	M016	10/02/2023

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp		064187883	manufacture(51514-0363)