Walgreens Camphor Phenol Gel: Package Insert and Label Information

WALGREENS CAMPHOR PHENOL GEL- camphor (synthetic) and phenol gel
Walgreens

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.

Active ingredient

Camphor (10.8%), Phenol (4.7%)

Purpose

Pain reliever/antiseptic

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away. Do not induce vomiting before contacting medical help or a Poison Control Center.

Uses

For the temporary relief of pain and itching associated with cold sores and fever blisters. First aid to help prevent infection.

Warnings

For external use only. Do not use over large areas of the body or with a bandage. Ask a doctor before use if you have a deep or puncture wound. Animal bites. Serious burns. When using this product do not use near the eye. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

Directions

Adults and children 2 years or over: clean the affected area. Apply directly to the cold sore or fever blister 1 to 3 times daily. Do not bandage. Children under 2 years: ask a doctor.

Inactive Ingredients

Eucalyptus, Glycerin, Mineral Oil, Silica.

Package/Label Principal Display Panel

Walgreens Art Work -- Box
(click image for full-size original)
WALGREENS CAMPHOR PHENOL GEL
camphor, phenol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9425
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 10.8 mg in 1 g
PHENOL (PHENOL) PHENOL 4.7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
LIGHT MINERAL OIL 77.75 mg in 1 g
SILICON DIOXIDE 5.75 mg in 1 g
GLYCERIN 0.5 mg in 1 g
EUCALYPTUS OIL 0.500 mg in 1 g
Product Characteristics
Color YELLOW Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-9425-01 1 g in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 08/31/2017
Labeler — Walgreens (008965063)
Registrant — Walgreens (008965063)
Establishment
Name Address ID/FEI Operations
OraLabs, Inc. 801824756 MANUFACTURE (0363-9425), LABEL (0363-9425)

Revised: 08/2017 Walgreens

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