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NDC 51824-0088-01 CAREALL Anti-Itch 20; 1 mg/g; mg/g Details

CAREALL Anti-Itch 20; 1 mg/g; mg/g

CAREALL Anti-Itch is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by New World Imports, Inc. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE.

MedlinePlus Drug Summary

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 51824-0088-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Product Information

NDC	51824-0088
Product ID	51824-088_8bf2602b-cadd-4dc7-bf96-bb3e7ad800c9
Associated GPIs
GCN Sequence Number	024972
GCN Sequence Number Description	diphenhydramine HCl/zinc acet CREAM (G) 2 %-0.1 % TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	67334
HICL Sequence Number	009759
HICL Sequence Number Description	DIPHENHYDRAMINE HCL/ZINC ACETATE
Brand/Generic	Generic
Proprietary Name	CAREALL Anti-Itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	diphenhydramine hydrochloride and zinc acetate cream
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20; 1
Active Ingredient Units	mg/g; mg/g
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Labeler Name	New World Imports, Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 51824-0088-01 (51824008801)

Pricing Information	N/A
NDC Package Code	51824-088-01
Billing NDC	51824008801
Package	35 g in 1 TUBE (51824-088-01)
Marketing Start Date	2022-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3a01f57a-ebc6-4724-b625-1d1ea4b85e73 Details

Active Ingredients

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Diphenhydramine Hydrochloride 2%....Topical Analgesic

Zinc Acetate 0.1%.............................Skin Protectant

Keep out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy / poison oak / poison sumac.
dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only.

Due not use:

on large areas of the body
with any other product containing diphenhydramine, even one taken by mouth.

Ask a doctor before use:

on chicken pox
on measles

When using this product avoid contact with eyes

Stop use and ask a doctor if:

condition worsens or does not improve within 7 days
symptoms persists for more than 7 days or clear up and occur again within a few days

Directions

do not use more than directed
adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years of age: ask a doctor

Inactive Ingredients

cetyl alcohol, glyceryl monostearate, glycerin, methylparaben, propylparaben, carbopol 980, light liquid paraffin, polysorbate 60, stearic acid, purified water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL ANTI-ITCH

diphenhydramine hydrochloride and zinc acetate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51824-088
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Cetyl Alcohol (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOMER 980 (UNII: 4Q93RCW27E)
PARAFFIN (UNII: I9O0E3H2ZE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51824-088-01	35 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/01/2022

Labeler - New World Imports, Inc (075372276)

Revised: 1/2022

Document Id: 8bf2602b-cadd-4dc7-bf96-bb3e7ad800c9

Set id: 3a01f57a-ebc6-4724-b625-1d1ea4b85e73

Version: 1

Effective Time: 20220113