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NDC 69842-0638-01 CVS Pharmacy .0013; .05 g/g; g/g Details

CVS Pharmacy .0013; .05 g/g; g/g

CVS Pharmacy is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is BENZALKONIUM CHLORIDE; BENZOCAINE.

Product Information

NDC	69842-0638
Product ID	69842-638_45d94180-4436-7298-e054-00144ff88e88
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 Pharmacy
Proprietary Name Suffix	Sensitive Medicated Cream
Non-Proprietary Name	Benzocaine, Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.0013; .05
Active Ingredient Units	g/g; g/g
Substance Name	BENZALKONIUM CHLORIDE; BENZOCAINE
Labeler Name	CVS Pharmacy
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0638-01 (69842063801)

Pricing Information	N/A
NDC Package Code	69842-638-01
Billing NDC	69842063801
Package	1 TUBE in 1 CARTON (69842-638-01) / 42.5 g in 1 TUBE
Marketing Start Date	2005-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 454c3458-7e40-0e5e-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

Active Ingredients

Benzocaine 5%

Benzalkonium Chloride 0.13%

Purpose

Topical Analgesic

First Aid Antiseptic

Uses

First aid temporary relief from the discomforts affecting the external area surrounding the vagina:

Itching
Burning
Irritation
Skin infections

Warnings

For external use only.

Do not use if you have unusual or abnormal vaginal discharge except under the supervision of your doctor.

When using this product

Wash hand thoroughly with soap and water before and after use
Avoid contact with eyes.
If burning sensation occurs and lasts more than a few minutes remove the cream and discontinue use.
Do not use more than 1 week unless directed by a doctor

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
side effect occur. You may report sude effect to FDA at 1-800-FDA-1088

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately. If in eyes, flush with water for 15 minutes and call a physician.

SPL UNCLASSIFIED SECTION

Apply to the affected area.
Because the area may already be irritated you could experience a slight burning sensation. If this persists more than a few minutes, remove cream and discontinue use.
Wash hand thoroughly with soap and water before and after use.

SPL UNCLASSIFIED SECTION

Store at room temperature. For lot number and expiration dates see crimp of tube or side of box.

SPL UNCLASSIFIED SECTION

Deionized Water, Glycerol Monostearate, Mineral Oil, PEG 100 Stearate, Cetyl Alcohol, Fragrance, Aloe Vera Gel, Lanolin Alcohol, Isopropyl Myristate, Isopropyl Stearate, Isopropyl Palmitate, Triethanolamine, Methylparaben, Propylparaben, Carbomer, Tocopheryl Acetate (Vitamin E), Trisodium HEDTA.

Questions or Comments

1-800-635-3696

SPL UNCLASSIFIED SECTION

Adults and children 2 years and over: Apply to the affected area not more than 3 to 4 times daily.
Children under 2 years: Do not use-consult a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS PHARMACY SENSITIVE MEDICATED CREAM

benzocaine, benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-638
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.05 g in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-638-01	1 in 1 CARTON	05/01/2005
1		42.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/01/2005

Labeler - CVS Pharmacy (062312574)

Revised: 1/2017

Document Id: 45d94180-4436-7298-e054-00144ff88e88

Set id: 454c3458-7e40-0e5e-e054-00144ff8d46c

Version: 2

Effective Time: 20170104

Search by Drug Name or NDC

NDC 69842-0638-01 CVS Pharmacy .0013; .05 g/g; g/g Details

CVS Pharmacy .0013; .05 g/g; g/g

Product Information

Package

Package Images

NDC 69842-0638-01 (69842063801)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 454c3458-7e40-0e5e-e054-00144ff8d46c Details

SPL UNCLASSIFIED SECTION

Purpose

Uses

Warnings

When using this product

Stop use and ask a doctor if

Keep out of reach of children

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Questions or Comments

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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