Simply Numb Endure (Lidocaine) Cream [Golden Touch Llc] -

SIMPLY NUMB ENDURE (LIDOCAINE) CREAM [GOLDEN TOUCH LLC]
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NDC	52763-604-80
Set ID	220bf5c6-b113-46fa-924d-8093473e2a30
Category	HUMAN OTC DRUG LABEL
Packager	Golden Touch LLC
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART346

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Active ingredient

Lidocaine 5% W/W
Purpose

Topical Anesthetic
KEEP OUT OF REACH OF CHILDREN

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

For the temporary relief of pain and itching
Warnings
For external use only

When using this product
- Avoid contact with the eyes
- Do not put in rectum
- Do not exceed recommended dosage unless directed by a doctor
Stop use and ask a doctor if
- allergic reaction occurs
- condition worsens or does not improve within 7 days
- Symptoms clear up and return within a few days
- rectal bleading occurs
- redness irritation swelling pain or other symptoms develop or increase
Directions
- Adults when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- Apply externally to the affected area up to 6 times daily.
- Children under 12 years of age: consult a doctor
Inactive ingredients

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Monooleate, SD Alcohol 40-B, Simmondsia Chinensis (Jojoba) Seed Oil, Water
Packaging

INGREDIENTS AND APPEARANCE

SIMPLY NUMB ENDURE
lidocaine cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL OLEATE (UNII: 4PC054V79P)
ALCOHOL (UNII: 3K9958V90M)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52763-604-80	480 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	07/08/2014

Labeler - Golden Touch LLC (194284147)

Name	Address	ID/FEI	Business Operations
Establishment
Golden Touch LLC		194284147	manufacture(52763-604)

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