AFTERSUN COOLING CVS- lidocaine 0.5% gel
CVS

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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Active Ingredients

Ludocaine 0.5%

Purpose

Pain Reliever

Uses

temporary relief of pain and itching due to sunburn

insect bites
cuts
scrapes

Warnings

For external use only

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

When using this product

avoid contact with eyes.
Rinse with water if contact occurs

Stop use and ask a doctor if

condition worsens or clear up and occur again within a few days
if symptoms persist for more than 7 days

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directiona

adults and children 2 years and older; apply to affected area not more than 3-4 timeas a day
children under 2 years of age: consult a physician

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzophenone-4, Blue1, Carbomer, Isoceteth-20, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Triethanolamine.

CVS

pharmacy

AFTERSUN

COOLING GEL

WITH LIDOCAINE

ALOE VERA

Soothes, cools & moisturizes skin

20 FL OZ (592 mL)

image description

AFTERSUN COOLING CVS
lidocaine 0.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-362
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ISOCETETH-20 (UNII: O020065R7Z)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-362-06	592 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package	11/11/2014	02/23/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/11/2014	02/23/2018

Labeler - CVS (062312574)

Registrant - Product Quest Mfg, LLC (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg, LLC		927768135	manufacture(59779-362) , label(59779-362)

Revised: 2/2018

Document Id: f51bffcf-e246-48a0-b8f2-1eada6876add

Set id: 5c2f26a8-6d70-4cdc-bf56-419a3a65557c

Version: 2

Effective Time: 20180226

CVS