ULTRA BLUE- 4% menthol gel 
BNG Enterprises DBA Herbal Clean

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.

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Active ingredient section

Menthol (4%)

Purpose

Topical Analgesic

Uses:

Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, sprains, strains, bruises.

Warnings

For external use only.

Stop Use and Ask a Doctor If

• Condition worsens

• Symptoms last more than 7 days or clear up and occur again within a few days

• A rash or irritation develops

Keep out of reach of children

If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When Using This Product

• Do not apply to wounds or damaged skin

• Do not bandage tightly

• Do not use in or near the eyes; if product gets into eyes, rinse thoroughly with water

• Do not use with electric heating pad

Directions

• Adults and children 2 years and older, apply directly to affected area; not more than 3 or 4 times daily

• Children under 2 years, ask a doctor

Inactive Ingredients:

Purified Water, Propylene Glycol, Emu Oil, Methylsulfonylmethane (msm), Polyacrylamide (and) C13-14 Isoparaffin and Laureth-7, C12-15 Alkyl Benzoate, Dimethicone, Dioctyl Adipate (and) Octyl Stearate (and) Octyl Palmitate, White Willow Extract, Propylene Glycol (and) Diazolidinyl Urea (and) Methylparaben (and) Propylparaben, Aloe Vera Gel, Panthenol, Ascorbic Acid, Capsicum Oleoresin, Cornflower Extract, Chamomile Extract, Feverfew Extract, Hypericum Extract, Calendula Extract, Linden Extract, Coriander Oil, Grape Seed Extract, Benzophenone-4, Polysorbate-20, Tetrasodium EDTA, Citric Acid, Fragrance, F D & C Blue #1 Lake

Ultra Blue tube front panel, back panel

Ultra Blue Tube

ULTRA BLUE 
4% menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70632-825
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4.56 g  in 114 g
Inactive Ingredients
Ingredient NameStrength
EMU OIL (UNII: 344821WD61)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70632-825-045000 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2018
Labeler - BNG Enterprises DBA Herbal Clean (781993902)
Establishment
NameAddressID/FEIBusiness Operations
Personal Care Performance Group144297160manufacture(70632-825)

Revised: 4/2019
Document Id: 86e806a0-09fa-49b1-e053-2991aa0aa235
Set id: 60bab646-6712-43eb-e053-2a91aa0ac939
Version: 3
Effective Time: 20190419
 
BNG Enterprises DBA Herbal Clean