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 the 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 yeas of age: Consult a doctor

Other Information

Store at room temperature
Avoidexcessive heat

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

Tube and Carton Labels

Tube Carton Label Tube Label

BLUESTOP MAX
external analgesic cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82714-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg in 1 g
MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W)	MENTHOL, (+)-	10 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:82714-002-01	1 in 1 CARTON	01/10/2023
1		85 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Clavel Corporation (927855643)

Name	Address	ID/FEI	Business Operations
Establishment
TAKA USA dba Cosmetic Innovations		802860515	manufacture(82714-002)

BlueStop Max Cream