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NDC 36800-0622-64 topcare anti itch 2; .1 g/100g; g/100g Details

topcare anti itch 2; .1 g/100g; g/100g

topcare anti itch is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE.

Product Information

NDC	36800-0622
Product ID	36800-622_1c8c862b-2550-418c-940f-6682b997f674
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	topcare anti itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	diphenhydramine hydrochloride, zinc acetate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	2; .1
Active Ingredient Units	g/100g; g/100g
Substance Name	DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Labeler Name	Topco Associates LLC
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	2024-12-31

Package

Package Images

NDC 36800-0622-64 (36800062264)

Pricing Information	N/A
NDC Package Code	36800-622-64
Billing NDC	36800062264
Package	1 TUBE in 1 CARTON (36800-622-64) / 28 g in 1 TUBE
Marketing Start Date	2020-04-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e0fb332a-2903-41ef-b35b-7cd3a74cff99 Details

Active ingredients

Diphenhydramine hydrochloride 2%

Zinc acetate 0.1%

Purpose

Topical analgesic

Skin protectant

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 and poison sumac
•: dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

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 a doctor before use

•: on chicken pox
•: on measles

When using this product

•: avoid contact with the eyes

Stop use and ask a doctor if

•: condition worsens or does not improve within 7 days
•: 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

•: do not use more than directed
•: adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
•: children under 2 years of age: ask a doctor

Other information

•: store at 20°-25°C (68°-77°F)

Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water

Questions or comments?

1-888-423-0139

Package/Label Principal Display Panel

COMPARE TO EXTRA STRENGTH BENADRYL® ITCH STOPPING CREAM ACTIVE INGREDIENTS

Itch Relief Cream

RELIEVES:

• Insect Bites, Minor Skin Irritations & Rashes Due to Poison Ivy, Poison Oak & Poison Sumac

TopCare® health

EXTRA STRENGTH

Anti-Itch Cream 2%

DIPHENHYDRAMINE HYDROCHLORIDE 2% & ZINC ACETATE 0.1%

Topical Analgesic & Skin Protectant

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

TOPCARE ANTI ITCH

diphenhydramine hydrochloride, zinc acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-622
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PEG-2 STEARATE (UNII: 94YQ11Y95F)
PEG-20 STEARATE (UNII: NBX892EA57)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-622-64	1 in 1 CARTON	04/08/2020
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	04/08/2020

Labeler - Topco Associates LLC (006935977)

Revised: 2/2022

Document Id: 1c8c862b-2550-418c-940f-6682b997f674

Set id: e0fb332a-2903-41ef-b35b-7cd3a74cff99

Version: 3

Effective Time: 20220225