CYHOT Cream with Lidocaine Well At WAlgreens: Package Insert and Label Information

CYHOT CREAM WITH LIDOCAINE WELL AT WALGREENS- lidocaine hydrochloride and menthol cream
Walgreens

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.

Active ingredients Purpose

Lidocaine HCL 4%……………………….Topical analgesic

Menthol 1%……………………………….Topical analgesic

Uses

Temporarily relieves pain and itching due to:
• sunburn • minor burns • minor cuts • scrapes • insect bites

Warnings For external use only

Do not use • in large quantities, particularly over raw surface or blistered areas

When using this product

•avoid contact with eyes

• do not apply to wounds or damages skin
• do not bandage tightly or use with a heating pad
• use only as directed

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

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

Directions

• adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Aloe Barbadensis Leaf Extract
Aminomethyl Propanol
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer
Caprylyl Methicone
Cetearyl Alcohol
Ceteth-20 Phosphate
Dicetyl Phosphate
Dimethicone
Disodium EDTA
Ethylhexylglycerin
Glyceryl Stearate SE
Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer
Isohexadecane
Methylparaben
Polysorbate 60
SD Alcohol 40
Steareth-21Water

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CYHOT CREAM WITH LIDOCAINE WELL AT WALGREENS lidocaine hci 4% menthol 1% cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 mL
Menthol (MENTHOL) Menthol 1 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
AMINOMETHYLPROPANOL
CAPRYLYL TRISILOXANE
CETOSTEARYL ALCOHOL
Ceteth-20 Phosphate
DIHEXADECYL PHOSPHATE
Dimethicone
EDETATE DISODIUM
Ethylhexylglycerin
GLYCERYL STEARATE SE
Isohexadecane
Methylparaben
Polysorbate 60
ALCOHOL
Steareth-21
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1111-03 1 BOTTLE in 1 CARTON contains a BOTTLE
1 80 mL in 1 BOTTLE This package is contained within the CARTON (0363-1111-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/15/2017
Labeler — Walgreens (008965063)
Registrant — Product Quest Mfg (927768135)
Establishment
Name Address ID/FEI Operations
Product Quest Mfg 927768135 manufacture (0363-1111), label (0363-1111)

Revised: 02/2018 Walgreens

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