FIRST AID SENSITIVE ANTI-ITCH- pramoxine hydrochloride 1.0% lotion

First Aid Sensitive Anti-Itch by

Drug Labeling and Warnings

First Aid Sensitive Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                   Purpose
Pramoxine Hydrochloride 1.0%.............External Analgesic

PURPOSE

INDICATIONS & USAGE

Uses

For temporary relief of pain and itching associated with
minor burns sunburn minor cuts scrapes insect bites
minor skin irritations

WARNINGS

Warnings
For external use only
When using this product
avoid contact with the eyes.
Stop use and ask a doctor if
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions
To open, squeeze cap tightly and turn pump counter-clockwise. 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: Consult a doctor

Inactive ingredients

Aloe Barbadensis Leaf Juice
Carbomer
Cetyl Alcohol
Chamomilla Recutita (Matricaria) Flower Extract
Ethylhexylglycerin
Glyceryl Stearate
Isopropyl Myristate
PEG-100 Stearate
PEG-8 Stearate
Petrolatum
Phenoxyethanol
Sodium Hydroxide
Stearic Acid
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIRST AID SENSITIVE ANTI-ITCH 
pramoxine hydrochloride 1.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	Pramoxine Hydrochloride	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Cetyl Alcohol (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
PEG-100 Stearate (UNII: YD01N1999R)
PEG-8 Stearate (UNII: 2P9L47VI5E)
Petrolatum (UNII: 4T6H12BN9U)
Phenoxyethanol (UNII: HIE492ZZ3T)
Sodium Hydroxide (UNII: 55X04QC32I)
Stearic Acid (UNII: 4ELV7Z65AP)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1236-6	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/31/2012

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-1236) , label(11822-1236)