L-Topical CALAMINE 8% PRAMOXINE HCL 1% LOTION

L-Topical CALAMINE 8% PRAMOXINE HCL 1% by

Drug Labeling and Warnings

L-Topical CALAMINE 8% PRAMOXINE HCL 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]

L-TOPICAL CALAMINE 8% PRAMOXINE HCL 1%- calamine, pramoxine hydrochloride lotion 
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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L-Topical CALAMINE 8% PRAMOXINE HCL 1% LOTION

DRUG FACTS

Active ingredient

Calamine 8%
Pramoxine HCl 1%

Purpose

Skin protectant
Topical analgesic

USES

Temporarily relieves pain and itching associated with:
 Rashes due to poison ivy, Poison oak or poison sumac Insect bites Minor skin irritation Minor cuts Dries the oozing and weeping of poison ivy, poison oak and poison sumac

WARNINGS

For external use only.

When using this product do not get into eyes

Stop use and ask a doctor if
 Condition worsens or does not improve within 7 days
Symptoms persist for more than 7 days or clear up and occur again within a few days

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

DIRECTIONS

 Shake well before use  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: ask a doctor

OTHER INFORMATION

Store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENTS

SD Alcohol 38-B, Camphor, Diazolidinyl urea, Fragrance, Hypromellose, Methylparaben, Polysorbate 80, Propylene glycol, Propylparaben, Purified water, Xanthan gum

QUESTIONS/COMMENTS

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

Calamine Plus Itch Reliever

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

L-TOPICAL CALAMINE 8% PRAMOXINE HCL 1% 
calamine, pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-036-04	118 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2021	02/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	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(73921-036)

Revised: 2/2023

Document Id: f42ad874-1142-1ea4-e053-2995a90a9e03

34390-5

Set id: 5dd9a3f3-227b-440e-8867-3e0187f86093

Version: 2

Effective Time: 20230208