Label: BUMP AND BRUISE RELIEVER- menthol cream
- NDC Code(s): 72663-636-67
- Packager: Welly Health PBC
- 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 February 25, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Flammable: Keep away from excessive heat or open flame.
Ask a doctor before use if you have: sensitive skin
When using this product • Avoid contact with the eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with
other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage
• Wash hands after use with cool water • Do not use with heating pad or device
Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur
If pregnant or breastfeeding: Ask a health professional before use
- Directions
- Other information
- Inactive Ingredients
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SPL UNCLASSIFIED SECTION
Menthol Pain Relief Cream
FREE FROM
x
Alcohol
Parabens
Sulfates
Mineral Oil
Fragrance
FRAGRANCE FREE
KID FRIENDLY
MADE WITH SQUEAKY CLEAN INGREDIENTS FOR HAPPY HEALING
SQUEAKY CLEAN FIRST AID
Formulated with naturally derived plant-based ingredients
ARNICA known to help minimize the appearance of bruises
CASTOR OIL known to help soothe skin
HELPS PROVIDE TEMPORARY PAIN RELIEF FROM
aches
sore muscles
sprains
bruises
Packaging is recyclable.
Distributed by Welly Health PBC
Minneapolis, MN 55402
1-833-BE-WELLY | getwelly.com
Product of USA and Canada with globally sourced materials.
- Packaging
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INGREDIENTS AND APPEARANCE
BUMP AND BRUISE RELIEVER
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72663-636 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CASTOR OIL (UNII: D5340Y2I9G) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITOL (UNII: 506T60A25R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72663-636-67 1 in 1 CARTON 03/01/2022 1 57 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 not final part348 03/01/2022 Labeler - Welly Health PBC (116766884)
