Label: CBD4 FREEZE PUMP VANISHING SCENT- lidocaine, menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 80875-421-60 - Packager: HMP BRANDS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Use
- Warnings
- Do not use
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WHEN USING
When using this product
- Use only as directed.
- Read and follow all directions and warnings on this label.
- Rare cases of serious burns have been reported with products of this type.
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with a medicated patch.
- Avoid contact with eyes and mucous membranes.
- A transient burning sensation may occur upon application but generally disappears in several days.
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STOP USE
Stop use and ask a doctor if
- condition worsens.
- redness is present.
- irritation develops.
- symptoms persist for more than 7 days or clear up and occur again within a few days.
- You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
If pregnant or breast-feeding, ask a healthcare professional before use..
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- PRODUCT LABEL
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INGREDIENTS AND APPEARANCE
CBD4 FREEZE PUMP VANISHING SCENT
lidocaine, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80875-421 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CANNABIDIOL (UNII: 19GBJ60SN5) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) METHYLPARABEN (UNII: A2I8C7HI9T) PEPPERMINT OIL (UNII: AV092KU4JH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80875-421-60 60 g in 1 TUBE; Type 0: Not a Combination Product 10/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/29/2020 Labeler - HMP BRANDS, LLC (117688328) Establishment Name Address ID/FEI Business Operations HMP BRANDS, LLC 117688328 manufacture(80875-421)