Label: CUROLOGY BARRIER BALM- skin barrier balm ointment
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NDC Code(s):
82575-302-01,
82575-302-02,
82575-302-03,
82575-302-04, view more82575-302-05, 82575-302-06
- Packager: Curology
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CUROLOGY BARRIER BALM
skin barrier balm ointmentProduct 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)