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NDC 47682-0697-35 Green Guard Maximum Strength Hydrocortisone 10 mg/g Details

Green Guard Maximum Strength Hydrocortisone 10 mg/g

Green Guard Maximum Strength Hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is HYDROCORTISONE.

MedlinePlus Drug Summary

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Related Packages: 47682-0697-35
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical

Product Information

NDC	47682-0697
Product ID	47682-697_ebe115d6-1ea7-380a-e053-2a95a90a5947
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	Green Guard Maximum Strength Hydrocortisone
Proprietary Name Suffix	n/a
Non-Proprietary Name	1% Hydrocortisone
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	HYDROCORTISONE
Labeler Name	Unifirst First Aid Corporation
Pharmaceutical Class	Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 47682-0697-35 (47682069735)

Pricing Information	N/A
NDC Package Code	47682-697-35
Billing NDC	47682069735
Package	144 PACKET in 1 BAG (47682-697-35) / .9 g in 1 PACKET
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8ee7a62a-7724-21e9-e053-2995a90a4501 Details

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Antipruritic (ant-itch)

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes
for external genital, feminine, and anal itching
other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only.

Do not use

for the treatment of diaper rash
with any other Hydrocortisone product unless you have consulted a doctor
if you have a vaginal discharge, consult a doctor

When using this product

avoid contact with eyes
do not put this product into rectum by using fingers, mechanical device or applicator
do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
rectal bleeding occurs

KEEP OUT OF REACH OF CHILDREN.

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

Directions

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: do not use and ask a doctor

For external anal and genital itching in adults:

when practical, clean affected area with mild soap and warm water and rinse thoroughly
gently dry by patting or blotting with toilet tissue or a soft cloth before applying

Children under 12 years of age: ask a doctor

Other information

store at room temperature 59° to 86° F (15° to 30° C)
tamper evident, do not use if packet is torn, cut or opened
avoid excessive heat and humidity

Inactive ingredients

benzoic acid, chlorphenesin, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80, purified water, titanium dioxide, trisodium citrate

Questions or comments?

1-800-869-6970

Green Guard Maximum Strength Hydrocortisone Cream 1%

Green Guard®

Maximum Strength

Hydrocortisone Cream 1%

For the temporay relief of itching

INGREDIENTS AND APPEARANCE

GREEN GUARD MAXIMUM STRENGTH HYDROCORTISONE

1% hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-697
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:47682-697-73	25 in 1 BOX	01/01/2020
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:47682-697-35	144 in 1 BAG	01/01/2020
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC:47682-697-99	0.9 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/01/2020

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 10/2022

Document Id: ebe115d6-1ea7-380a-e053-2a95a90a5947

Set id: 8ee7a62a-7724-21e9-e053-2995a90a4501

Version: 5

Effective Time: 20221025