THAYERS TOPICAL PAIN RELIEVER MEDICATED SUPERHAZEL WITH ALOE VERA FORMULA- camphor liquid
Henry Thayer Company

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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THAYERS TOPICAL PAIN RELIEVER MEDICATED SUPERHAZEL with ALOE VERA FORMULA

Active ingredient

Camphor 0.1%

Purpose

External Analgesic

Uses

For temporary relief of pain and itching associated with minor burns, scrapes, insect bites, or minor skin irritations.

Warnings

Stop use and ask a doctor if

symptoms last longer than 7 days or clear up and reoccur within a few days.

When using this product

For external use only
Avoid contact with the eyes

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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.

Other information

Store at 15 o - 30 o C (59 o - 86 o F) away from direct sunlight.

Inactive ingredients

Aloe Vera Extract (Certified Organic), Calendula Extract, Citric Acid, Clove Oil, Denatured Grain Alcohol (20% v/v), Eucalyptol, Glycerin (Vegetable), Grapefruit Seed Extract, Peppermint Oil, Purified Water, Witch Hazel (THAYERS propietary un-distilled Certified Organic).

Questions or Comments?

Contact: Sam Carley 1-888-THAYER-1 (1-888-842-9371) www.thayers.com • E-mail: info@thayers.com Monday - Friday 9 am to 5 pm EST

THAYERS TOPICAL PAIN RELIEVER MEDICATED SUPERHAZEL with ALOE VERA FORMULA 12 FL OZ / 355ml

Liquid Label

THAYERS TOPICAL PAIN RELIEVER MEDICATED SUPERHAZEL WITH ALOE VERA FORMULA
camphor liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11109-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CLOVE OIL (UNII: 578389D6D0)
EUCALYPTOL (UNII: RV6J6604TK)
GLYCERIN (UNII: PDC6A3C0OX)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
WITCH HAZEL (UNII: 101I4J0U34)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11109-000-00	1 in 1 CARTON	09/18/2013	04/30/2018
1		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/18/2013	04/30/2018

Labeler - Henry Thayer Company (001012293)

Name	Address	ID/FEI	Business Operations
Establishment
Harrison Specialty Co., Inc.		001000355	manufacture(11109-000)

Revised: 10/2016

Document Id: 3fb2ec90-071e-5c34-e054-00144ff8d46c

Set id: 3b78bb47-7ce8-4f78-84a4-a53519f43668

Version: 2

Effective Time: 20161025

Henry Thayer Company