BLUESTOP MAX- external analgesic gel

BlueStop Max by

Drug Labeling and Warnings

BlueStop Max by is a Otc medication manufactured, distributed, or labeled by Clavel Corporation, TAKA USA Inc, dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Purpose

Topical Analgesic

Use

Temporary relief of pain

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: Consult a doctor.

Other Information

Store at room temperature

Avoid excessive hrat

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol Acetate, Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate and Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.S), Cetyl Alcohol, Coconut Oil, Dimethyl Sulfone, Ethylhexylglycerin,Ethylhexyl Palmitate, Fragrance, Garcinia Indica Seed Butter, Glucosamine Sulfate, Glycerin, Melaleuca Alternifolia Leaf, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW), Vitamin A Palmitate, Water, Witch Hazel

Questions or Comments

1-800-432-5464

Roll-On Label and Carton Label

INGREDIENTS AND APPEARANCE

BLUESTOP MAX 
external analgesic gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82714-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WITCH HAZEL (UNII: 101I4J0U34)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82714-001-01	1 in 1 CARTON	01/10/2023
1		85 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/10/2023

Labeler - Clavel Corporation (927855643)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA Inc, dba Cosmetic Innovations		802860515	manufacture(82714-001)