Pain Gel by Good Clean Love, Inc. / TRI-PAC, INC. Pain Gel

Pain Gel by

Drug Labeling and Warnings

Pain Gel by is a Otc medication manufactured, distributed, or labeled by Good Clean Love, Inc., TRI-PAC, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN GEL- lidocaine hcl gel 
Good Clean Love, Inc.

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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Pain Gel

Active ingredients (per dose)

Lidocaine HCL 4%

Purpose

Lidocaine HCL 4%................Topical Analgesic

Uses

For temporary relief from vaginal pain, itch, and irritation

Warnings

For external use only. Avoid contact with eyes. Do not use on large areas of skin.

Ask a doctor before use if

• You are pregnant, trying to conceive, or breastfeeding

Stop use and ask doctor if

• Allergic reaction occurs
• Condition worsens or does not improve
• Redness, irritation, or swelling occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Clean area and gently dry irritated area
• Apply gel to vulva, labia and at the vaginal opening as needed to relieve itching, burning irritation, and to soothe irritated skin
• Clean nozzle after use & close tightly
• Do not apply more than 3-4 times daily unless directed by doctor

Other information

• Tamper resistant seal
• Do not use if seal is not intact
• Store at room temperature (68F-77F)

Inactive ingredients

Purified Water, Organic Aloe Barbadensis Leaf Juice, Propanediol, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Lactic Acid, Xanthan Gum, St. John’s Wort Extract, Linden Flower Extract, Green Tea Extract, Calendula Extract, Aspen Extract, Cornflower Extract, Roman Chamomile Extract, Sodium Benzoate, Potassium Sorbate, Glycerin

Questions or comments?

1-541-344-4483 Monday-Friday

9am-5pm or visit goodcleanlove.com

Good Clean Love

relief gel

Pain & Itch Gel

With Lidocaine 4%

Relieves irritation & external vaginal discomfort

Gynecologist Recommended

1 Fl Oz (29mL)

PAIN GEL 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73716-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
ST. JOHN'S WORT (UNII: UFH8805FKA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
LACTIC ACID (UNII: 33X04XA5AT)
XANTHAN GUM (UNII: TTV12P4NEE)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73716-002-29	1 in 1 CARTON	04/08/2022	04/08/2022
1		29 mL 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	04/08/2022	04/08/2022

Labeler - Good Clean Love, Inc. (153909531)

Establishment
Name	Address	ID/FEI	Business Operations
TRI-PAC, INC.		020844956	manufacture(73716-002)

Revised: 8/2022

Document Id: e5faa6e9-aa0d-1b01-e053-2995a90a7dbf

34390-5

Set id: dc69d1c6-77b9-4df0-e053-2a95a90ad3b1

Version: 2

Effective Time: 20220811