Label: CARE ONE ORIGINAL SPF 4 LIP BALM- padimate o, petrolatum stick
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Contains inactivated NDC Code(s)
NDC Code(s): 41520-979-02 - Packager: American Sales Company
- 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 March 11, 2013
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- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
- Warnings
- Directions
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
CARE ONE ORIGINAL SPF 4 LIP BALM
padimate o, petrolatum stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-979 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 44.0 mg in 1 g PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) 3.00 mg in 1 g LANOLIN (UNII: 7EV65EAW6H) 1 mg in 1 g CERESIN (UNII: Q1LS2UJO3A) 17.30 mg in 1 g CARNAUBA WAX (UNII: R12CBM0EIZ) 1 mg in 1 g ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 2.23 mg in 1 g LIGHT MINERAL OIL (UNII: N6K5787QVP) 27.50 mg in 1 g Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-979-02 1 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/15/2013 Labeler - American Sales Company (809183973) Registrant - American Sales Company (809183973) Establishment Name Address ID/FEI Business Operations OraLabs 801824756 MANUFACTURE(41520-979) , LABEL(41520-979)