CVS HEALTH AFTERSUN ALOE VERA COOLING- lidocaine gel

CVS Health by

Drug Labeling and Warnings

CVS Health by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Lidocaine 0.5%

Purpose

External Analgesic

Uses

For the temporary relief of sunburn, minor burns, minor cuts, scrapes, insect bites, minor rashes, minor skin irritations and windburned skin.

Warnings

• FOR EXTERNAL USE ONLY

DO NOT USE

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

When using this product

• Keep out of eyes and eyelids. If contact with eyes occurs, rinse with water to remove.

Stop use and ask a doctor if

• irritation or rash develops.
• condition worsens, or if 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, seek medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 2 years and older: apply to affected area not more than 3-4 times daily.
• Children under 2 years of age: ask a doctor.

Inactive ingredients

Aloe Vera Gel, Isoceteth-20, Triethanolamine, Carbomer 940, Tetrasodium EDTA, Methylchloroisothiazolinone (and) Methylisothiazolinone, Benzophenone-4, FD&C Blue #1.

PRINCIPAL DISPLAY PANEL

CVS Health

AFTERSUN
ALOE VERA
COOLING GEL
WITH LIDOCAINE

• Naturally soothes, cools & moisturizes skin
• Helps prevent drying & peeling
• Enriched with vitamin E

NET WT
6.0 OZ (170 g)

INGREDIENTS AND APPEARANCE

CVS HEALTH  AFTERSUN ALOE VERA COOLING
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
ISOCETETH-20 (UNII: O020065R7Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-107-15	170 g in 1 BOTTLE; Type 0: Not a Combination Product	01/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/12/2017

Labeler - CVS Pharmacy (062312574)

Registrant - Fruit of the Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboaratories, Inc.		008193513	manufacture(69842-107)