Assured by Anhui NHU Pharmaceutical Co., Ltd. Drug Facts

Assured by

Drug Labeling and Warnings

Assured by is a Otc medication manufactured, distributed, or labeled by Anhui NHU Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ASSURED- lidocaine hydrochloride gel 
Anhui NHU Pharmaceutical Co., Ltd.

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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Drug Facts

Inactive Ingredients   aloe barbadensis leaf juice,

benzalkonium chloride, carbomer 940, glycerin, menthol,

polysorbate 80, propylene glycol, sodium hydroxide, water

Active Ingredient

Lidocaine hydroxide 2.5 %

Purpose

Topical analgesic

Uses  for temporary relief of pain associated with

-minor burns  -sunburn

-minor cuts or scrapes   - minor skin irritations

Warnings

For external use only

Do not use

-in large quantities, particularly over raw surfaces

or blistered areas

When using this product

-avoid contact with eyes

Stop Use and ask a doctor

-if condition worsens, or if symptoms persist for more than

7 days or clear up and then occur again within a few

days, discontinue use of this product and consult

a physician

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

Directions

adults and children over 2 years of age:

-clean the affected area and gently dry

-apply to the affected area not more than 3 to 4 times daily

children under 2 years of age; consult a physician

Other Information

store at room temperature 59 - 86 F (15 - 30 C)

ASSURED 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-002-02	1 in 1 BOX	12/26/2015	03/31/2018
1	NDC: 69571-002-01	20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/26/2015	03/31/2018

Labeler - Anhui NHU Pharmaceutical Co., Ltd. (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
Anhui NHU Pharmaceutical Co., Ltd.		530897792	manufacture(69571-002)

Revised: 11/2019

Document Id: 9842b6ca-34f3-e6f1-e053-2995a90a0bac

34390-5

Set id: ba97c4ee-e097-4e9d-937a-f5ee4f9d6dfb

Version: 3

Effective Time: 20191126

 

Anhui NHU Pharmaceutical Co., Ltd.