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NDC 69842-0626-75 CVS Anti-Itch .5; .5 g/100g; g/100g Details

CVS Anti-Itch .5; .5 g/100g; g/100g

CVS Anti-Itch is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	69842-0626
Product ID	69842-626_87715662-c789-9a8d-e053-2a95a90acb53
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CVS Anti-Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Camphor, Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	.5; .5
Active Ingredient Units	g/100g; g/100g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL
Labeler Name	CVS
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0626-75 (69842062675)

Pricing Information	N/A
NDC Package Code	69842-626-75
Billing NDC	69842062675
Package	212 g in 1 BOTTLE, PUMP (69842-626-75)
Marketing Start Date	2016-04-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 87715662-c788-9a8d-e053-2a95a90acb53 Details

Active Ingredients

Camphor 0.5%............................................................................................................................ External analgesic

Menthol 0.5%.............................................................................................................................. External analgesic

Uses

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

dries the oozing and weeping of poison:

ivy

oak

sumac

Warning

For external use only

Do not use

on large areas of the body

with any other product containing diphenhydramine, even one taken by mouth

ASk doctor before use

on chicken pox

on measles

when using this product

do not get into eyes

Stop Use and ask 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 children

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

Purpose

Anti - itch

Directions

to open, squeeze cap tightly and turn pump counter-clockwise

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredients

carbomer 940, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl myristate, PEG-40 stearate,

PEG-100 stearate, purified water, sodium hydroxide, stearic acid, white petrolatum

Principal Display Panel

CVS Health

Compare to Sarna Original Anti-Itch lotion

Original Formula Anti-Itch Lotion

Camphor 0.5%

Menthol 0.5%

Steroid Free

Relief from itching associated with dry skin, insectr bites, poison ivy and Sunburn

Cools and Soothes

INGREDIENTS AND APPEARANCE

CVS ANTI-ITCH

camphor, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-626
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.5 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
PEG-40 STEARATE (UNII: ECU18C66Q7)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER 940 (UNII: 4Q93RCW27E)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69842-626-75	212 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/14/2016

Labeler - CVS (062312574)

Registrant - Weeks & Leo Co., Inc. (005290028)

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo		005290028	manufacture(69842-626)

Revised: 4/2019

Document Id: 87715662-c789-9a8d-e053-2a95a90acb53

Set id: 87715662-c788-9a8d-e053-2a95a90acb53

Version: 1

Effective Time: 20190426