S-Oint HYDROCORTISONE USP 1% OINTMENT

S-Oint HYDROCORTISONE 1% by

Drug Labeling and Warnings

S-Oint HYDROCORTISONE 1% by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

S-OINT HYDROCORTISONE 1%- hydrocortisone ointment 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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S-Oint HYDROCORTISONE USP 1% OINTMENT

Drug Facts

ACTIVE INGREDIENT

Hydrocortisone USP 1%

PURPOSE

Steroid Cream

USES

For relief of itching associated with minor skin irritations and rashes due to:  Eczema  Insect bites  Soaps and detergents  Cosmetics  Jewelry  Seborrheic dermatitis  Psoriasis  Poison ivy, oak or sumac  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  In children under 2 years of age  If you have a vaginal discharge  For the treatment of diaper rash

Ask a doctor before use if you have  External genital or feminine itching  External anal itching  Bleeding

When using this product  Avoid contact with eyes  Do not exceed the recommended daily dosage unless directed by a doctor  Do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor  If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use and do not begin use of any other hydrocortisone product, unless you have consulted a doctor.

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

DIRECTIONS

For minor skin irritations and rashes, adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. For external anal itching:  Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly  Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product  Children: under 12 years of age, consult a doctor.

OTHER INFORMATION

Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.  Store at room temperature  See crimp of tube or carton for Lot Number and Expiration Date

INACTIVE INGREDIENT

Paraffin wax, Microwax, Light liquid paraffin

Questions or comments?

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

MAXIMUM STRENGTH ANTI-ITCH OINTMENT

Helps relieve itching from eczema:
√Psoriasis
√Seborrheic dermatitis
√insect bites
√Skin irritation

Manufactured by :
Global Pharma Healthcare Pvt. Ltd.,
A-9, SIDCO Pharmaceutical Complex,
Alathur-603 110 - INDIA.
www.global-pharma.com

Packaging

S-OINT HYDROCORTISONE 1% 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-017
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LIGHT MINERAL OIL (UNII: N6K5787QVP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-017-30	1 in 1 CARTON	04/01/2021	02/08/2023
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-017)

Revised: 2/2023

Document Id: f42b38b2-1cea-bfdd-e053-2a95a90a1477

34390-5

Set id: 061e1cb3-9ed1-4367-9e2a-a5acaf46cf4a

Version: 2

Effective Time: 20230208