S-OINT DIAPER RASH AND SKIN PROTECTANT- lanolin, petrolatum 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 DIAPER RASH OINTMENT & SKIN PROTECTANT

DRUG FACTS

ACTIVE INGREDIENT

Lanolin 15.5%
Petrolatum 53.4%

PURPOSE

Diaper rash ointment
Skin Protectant

INACTIVE INGREDIENTS

Cod liver oil (Contains Vitamin A & vitamin D), Fragrance, Light mineral oil, Microcrystalline wax, Paraffin

USES

Helps treat and prevent diaper rash;

Temporarily protects & Soothes:
• Cuts • Scrapes • Burns
• Temporarily protects and helps relieve chapped, chafed or cracked skin and lips • Protect chafed skin due to diaper rash and helps seal out wetness

WARNINGS

For external use only

When using this product
• Do not get into eyes

Stop use and ask a doctor if
Condition worsens
Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on
• Seep or puncture wounds • Animal bites • Serious burns.

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

Questions or comments?

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

DIRECTIONS

For skin protectant use apply as needed

For diaper rash use:
Change wet and soiled diapers promptly
Cleanse the diaper area, and allow to dry
Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

OTHER INFORMATION

Store between 20°C to 25°C (68° to 77°F)

Store upright when not in use

Soothes:
Skin irritation
Abrasion / Scrapes
Minor Burns
Diaper Rash
Chafed / Cracked skin

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

Diaper20

S-OINT DIAPER RASH AND SKIN PROTECTANT
lanolin, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73921-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	155 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	534 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
COD LIVER OIL (UNII: BBL281NWFG)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PARAFFIN (UNII: I9O0E3H2ZE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73921-020-30	1 in 1 CARTON	04/01/2021	02/08/2023
1		30 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 final	part347	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Name	Address	ID/FEI	Business Operations
Establishment
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-020)

Revised: 2/2023

Document Id: f42b2336-f903-6394-e053-2a95a90ac573

Set id: 9f244a14-6342-4c03-b526-534750f5579e

Version: 2

Effective Time: 20230208

GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED