BARRIER BALM- barrier balm ointment 
Autumn Harp, Inc.

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Skin Barrier Balm

Active Ingredient

Petrolatum 41.9%

Dimethicone 13.0%

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

Directions

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

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

Questions?

858-859-1188

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

Apply as needed

48g tube carton artwork15g carton artwork with drug facts box28g carton artwork with drug facts box15g tube primary container image28g tube primary artwork image48g tube primary artwork image

BARRIER BALM 
barrier balm ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0363
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE 20 (UNII: H8YMB5QY0D) (DIMETHICONE 20 - UNII:H8YMB5QY0D) DIMETHICONE 2013 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0363-21 in 1 CARTON10/02/2023
1NDC:51514-0363-115 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51514-0363-41 in 1 CARTON10/02/2023
2NDC:51514-0363-328 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:51514-0363-61 in 1 CARTON10/02/2023
3NDC:51514-0363-548 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01610/02/2023
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp064187883manufacture(51514-0363)

Revised: 8/2023
Document Id: 01df9746-991c-4363-e063-6294a90aaac6
Set id: 01df9746-991b-4363-e063-6294a90aaac6
Version: 1
Effective Time: 20230801
 
Autumn Harp, Inc.