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NDC 69842-0588-28 Anti-Itch Medicated Maximum Strength 200; 30 mg/g; mg/g Details

Anti-Itch Medicated Maximum Strength 200; 30 mg/g; mg/g

Anti-Itch Medicated Maximum Strength is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Health. The primary component is BENZOCAINE; RESORCINOL.

Product Information

NDC	69842-0588
Product ID	69842-588_15fdd717-e419-42b1-ad9f-46873e96ede4
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	Anti-Itch Medicated Maximum Strength
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzocaine and Resorcinol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	200; 30
Active Ingredient Units	mg/g; mg/g
Substance Name	BENZOCAINE; RESORCINOL
Labeler Name	CVS Health
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 69842-0588-28 (69842058828)

Pricing Information	N/A
NDC Package Code	69842-588-28
Billing NDC	69842058828
Package	1 TUBE in 1 CARTON (69842-588-28) / 28 g in 1 TUBE
Marketing Start Date	2021-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 69aa1822-c96b-46a0-95a6-7a7857331c69 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzocaine 20%

Resorcinol 3%

Purpose

External analgesic

Use

temporarily relieves itching

Warnings

For external use only

Allergy Allert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics.

Avoid contact with eyes

in case of contact rinse thoroughly and immediately with water.

Stop use and ask doctor if

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

Directions

Adults and children 12 years and older

Apply a finger tip amount (approxiamtely a 1 inch strip) to the affected areas not more than 3 to 4 times daily

Children under 12 years

ask a doctor

Other Information:

questions?

Inactive ingredients

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium EDTA, Maltodextrin

Principal Display Panel- Tube

CVS NDC 69842-588-28

Maximum StrengthAnti-Itch Creme

NET WT 1 oz. (28 g)

Principal Display Panel- Carton

CVS 69842-588-28

MAXIMUM STRENGTH ANTI ITCH CREAM

NET WT 1.0 OZ (28g)

INGREDIENTS AND APPEARANCE

ANTI-ITCH MEDICATED MAXIMUM STRENGTH

benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-588
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
SODIUM SULFITE (UNII: VTK01UQK3G)
TROLAMINE (UNII: 9O3K93S3TK)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-588-28	1 in 1 CARTON	09/30/2021
1		28 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	09/30/2021

Labeler - CVS Health (062312574)

Name	Address	ID/FEI	Business Operations
Establishment
Sheffield Pharmaceuticals LLC		151177797	manufacture(69842-588)

Revised: 8/2021

Document Id: 15fdd717-e419-42b1-ad9f-46873e96ede4

Set id: 69aa1822-c96b-46a0-95a6-7a7857331c69

Version: 1

Effective Time: 20210825