Search by Drug Name or NDC

NDC 49035-0588-09 Itch and Bite Relief First Aid Kit Details

Itch and Bite Relief First Aid Kit

Itch and Bite Relief First Aid Kit is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by WAL-MART STORES, INC.. The primary component is .

Product Information

NDC	49035-0588
Product ID	49035-588_c8ad60e2-f392-9d3b-e053-2a95a90a2135
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	Itch and Bite Relief First Aid Kit
Proprietary Name Suffix	n/a
Non-Proprietary Name	Hydrocortisone and Diphenhydramine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	WAL-MART STORES, INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	n/a

Package

Package Images

NDC 49035-0588-09 (49035058809)

Pricing Information	N/A
NDC Package Code	49035-588-09
Billing NDC	49035058809
Package	1 KIT in 1 CASE (49035-588-09) * .9 g in 1 POUCH (61010-5800-1) * 1 TABLET, FILM COATED in 1 PACKET (47682-184-46)
Marketing Start Date	2019-10-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 912e8c82-570c-b6e6-e053-2995a90ae31a Details

Active ingredient (Hydrocortisone Cream)

Hydrocortisone 1.0%

Purpose(Hydrocortisone Cream)

Anti-itch

Uses (Hydrocortisone cream)

• For temporary relief of itching associated with minor skin irritations, inflammation, or rashes due to:

• eczemas

• insect bites

• poison ivy, oak or sumac

• soaps

• detergents

• cosmetics

• jewelry

• seborrheic dermatitis

• psoriasis

• Other uses of product should be only under the advice and supervision of a doctor.

Warnings(Hydrocortisone Cream)

For external use only

Do not use (Hydrocortisone cream)

• in the eyes

• for treatment of diaper rash

• for feminine itching

Ask a doctor before use if you are (Hydrocortisone cream)

• using any other hydrocortisone product

Stop use and ask a doctor if (Hydrocortisone cream)

the condition worsens or lasts more than 7 days, or clears up and occurs again within a few days

Keep out of reach of children (Hydrocortisone cream)

If ingested, contact a Poison Control Center right away

Directions (Hydrocortisone cream)

• Apply to affected area not more than 3 to 4 times daily

• Children under 2: ask a doctor

Other information (Hydrocortisone cream)

• Store at room temperature (do not freeze)

• Do not use any opened or torn packets

Inactive ingredients(Hydrocortisone cream)

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Active ingredient (in each caplet)(Diphen caplet)

Diphenhydramine Hydrochloride 25 mg

Uses (Diphen caplet)

Temporarily relieves these symptoms due to hay fever or other respiratory allergies

• runny nose • sneezing • itching of the nose or throat • itchy, watery eyes

Temporarily relieves these symptoms due to the common cold

• runny nose • sneezing

Warnings (Diphen caplet)

Do not use

• to make children sleepy

• with any other product containing diphenhydramine, even one that is used on skin.

Ask a doctor before use if you have (Diphen caplet)

• a breathing problem such as emphysema or chronic bronchitis

• difficulty in urination due to enlargement of the prostate gland

• glaucoma

When using this product (Diphen caplet)

• marked drowsiness may occur

• avoid alcohol beverages

• alcohol, sedatives and tranquilizers may increase the drowsiness effect

• use caution when driving a motor vehicle or operating machinery

• excitability may occur, especially in children

If pregnant or breast-feeding (Diphen caplet)

ask a health care professional before use.

Keep out of reach of children (Diphen caplet)

n case of overdose, contact a physician or poison control center immediately.

Directions (Diphen caplet)

• do not take more than directed

Adults and children (12 years and older): Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Other information (Diphen caplet)

• each caplet may contain: calcium 25mg

• store at room temperature 59º to 86ºF (15º to 30ºC)

• protect from light

• use by expiration date on packet

• tamper-evident sealed packetsM

• do not use any opened or torn packets

Inactive ingredients (Diphen caplet)

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate*, titanium dioxide

* may contain

First Aid Kit Package/Label Principal Display Panel

OZARK TRAIL

OUTDOOR EQUIPMENT

ITCH & BITE RELIEF

FIRST AID KIT

Ideal for minor insects bites and itches

9 PIECES

SEE BACK PANEL FOR KIT CONTENTS

First Aid Kit Pakcage/Label Principal Display Panel