BUMP AND BRUISE RELIEVER- menthol cream

Bump and Bruise Reliever by

Drug Labeling and Warnings

Bump and Bruise Reliever by is a Otc medication manufactured, distributed, or labeled by Welly Health PBC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Menthol 1.5%

Purpose

Pain Relief

Uses

Temporary relief from minor aches and pains of muscles & joints associated with: backache strains bruises sprains

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

Keep out of the reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

 Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily, massage not necessary

 Children under 2 years of age: Consult physician

Other information

Store in a cool dry place with lid closed tightly

Inactive Ingredients

Acrylamide Sodium Acryloyldimethyl Taurate Copolymer, Aqua, Arnica, Castor Oil, Cetostearyl Alcohol, Glycerin, Isohexadecane, Polysorbate 80,

Sodium Benzoate, Sorbitan Monooleate, Sorbitol

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

INGREDIENTS AND APPEARANCE

BUMP AND BRUISE RELIEVER 
menthol cream

Product 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)