DR BUMP GEL 4- menthol gel

Dr Bump gel 4 by

Drug Labeling and Warnings

Dr Bump gel 4 by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT

Menthol 5% Topical Analgesic

Other Safety Information

Protect this product from excessive heat and direct sun

OTC - ASK DOCTOR

Stop use and ask a doctor if redness is present.irritation develops. conditions worsens or symtoms persist more than 7 days. symtoms clear up and occur again within a few days

OTC - PURPOSE SECTION

Uses: for temporary relief of minor aches and pains of muscles and joints associated with. simple aches. back aches. arthritis.strains.bruises.sprains.

Keep out of reach of children

Keep out of reach of children

INACTIVE INGREDIENTS

Aesculus hippocastanum (Horse Chestnut), Aloe barbadensis miller, Aloe barbadensis miller (Aloe Vera), Amonium Acrylcydimethyltaurate/VPCcopolymer, Arnica montana (Arnica), Bromelain, Butylene Glycol, Capsicum annum (Capsicum), Chamaemelum nobile (Chamomile), Ethyl alcohol, Eucalyptus globules (Eucaliptus) oil, FD&C Green # 3, Glucosamine Sulfate, Harpagophytum procumbens (Devil’s Claw), Melissa officinalis (Lemon Balm), Methyl Sulfonyl Methane (MSM), Polysorbate-60, Potassium Sorbate, Purified Water, Rosmarinus officinalis (Rosemary), Salix alba (Willow Bark), Edetic Acid, Tilia cordata (Linden), Xanthan Gum

Warnings

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Dosage & Admnistration

External topical analgesic Topical massage gel no more than 4 times daily

Indications & usage

Apply generous amount of gel directly affected area massage into painful area until thoroughly absorbed into skin

Label

INGREDIENTS AND APPEARANCE

DR BUMP GEL 4 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ARNICA MONTANA (UNII: O80TY208ZW)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SALIX ALBA BARK (UNII: 205MXS71H7)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
BROMELAINS (UNII: U182GP2CF3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPSICUM (UNII: 00UK7646FG)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
MELISSA OFFICINALIS (UNII: YF70189L0N)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
ROSEMARY (UNII: IJ67X351P9)
EDETIC ACID (UNII: 9G34HU7RV0)
ALCOHOL (UNII: 3K9958V90M)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-052-18	120 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/30/2020

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture(35192-052)